Restrictions in sales for PVC medical devices
As amendments for RUSSIAN FEDERATION GOVERNMENT DECREE dated 5 February 2015 No. 102 – restrictions about PVC products.
Approved by Decree No. 968 of the Government of the Russian Federation
dated 14 August 2017
LIST OF DISPOSABLE MEDICAL PRODUCTS MADE OF POLYVINYL CHLORIDE PLASTICS ORIGINATING FROM FOREIGN STATES SUBJECT TO RESTRICTIONS IMPOSED WITH RESPECT TO APPROVAL THEREOF FOR PROCUREMENT FOR THE PURPOSE OF SATISFYING STATE AND MUNICIPAL NEEDS
List of amending documents (introduced by Decree No. 968 of the Government of the Russian Federation dated 14 August 2017)
| Name of medical device | Code in accordance with the All-Russian Classifier of Products by Types of Economic Activities (OKPD 2) ОК 034-2014 | Medical device type code <*> | Medical device type name <*> | Distinctive features of the relevant medical device type <*> | |||||||
| 1. | Devices for the transfusion of blood, blood substitutes and infusion solutions | 32.50.13.110 | 32.50.13.190 | 114090 | 131660 | 131850
131880 136330 145530 145570 167580 |
Devices (systems) for transfusion of blood, blood substitutes, and infusion solutions, including those with a microfilter, intended for the safe transfusion of blood and its components, blood substitutes and infusion solutions from polymeric and glass containers | ||||
| – | Devices for the transfusion of infusion solutions and blood substitutes (PR) | 136330 | Basic kit for intravenous infusions | ||||||||
| – | Devices for the transfusion of infusion solutions and blood substitutes (PR) | 131850 | Filter for infusion systems for intravenous infusions | ||||||||
| – | Devices for the transfusion of infusion solutions and blood substitutes (PR) | 131660 | Kit for extending the lines intended for intravenous infusions | ||||||||
| – | Devices for the transfusion of infusion solutions and blood substitutes (PR) | 131880 | Clamp for infusion systems designed for intravenous infusions equipped with a calibrated circular scale | ||||||||
| – | Devices for the transfusion of infusion solutions and blood substitutes (PR) | 114090 | Kit for intravenous infusions made from non-absorbent material | ||||||||
| – | Devices for the transfusion of infusion solutions and blood substitutes (PR) | 167580 | Kit for intravenous infusions equipped with a heating element | ||||||||
| – | Devices for the transfusion of blood, blood components, and blood substitutes (PK) | 145570 | Blood transfusion kit | ||||||||
| – | Devices for the transfusion of blood, blood components, and blood substitutes equipped with a microfilter (PK equipped with a microfilter) | 145570 | Blood transfusion kit | ||||||||
| – | Devices for the transfusion of blood, blood components, and blood substitutes equipped with a microfilter (PK equipped with a microfilter) | 145530 | Blood transfusion filter | ||||||||
| 2. | Containers for harvesting, storage, and transportation of donor blood and its components | 32.50.13.190 | 32.50.50.000 | 144260 | 144270 | 144290
144300 144310 144320 145490 169870 178820 322610 |
Containers for harvesting, storage and transportation of donor blood and its components, including those equipped with a leukofilter, for obtaining whole blood from donors as well as donor blood components: erythrocyte mass, plasma, platelet concentrate and platelet-leukocyte mass, including blood components depleted of leukocytes | ||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components without haemopreservatives (dry), single-chamber (1000 ml) | ||||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components without haemopreservatives (dry), single-chamber (300-450 ml) | ||||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components without haemopreservatives (dry), dual-chamber | ||||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative, single-chamber | 144260 | Kit for donor blood, single-chamber | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative, dual-chamber | 144270 | Kit for donor blood, dual-chamber | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative, triple-chamber | 144320 | Kit for donor blood, triple-chamber | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative, four-chamber | 144300 | Kit for donor blood, four-chamber | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative | 178820 | Paediatric kit for donor blood | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter | 144320 | Kit for donor blood, triple-chamber | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter | 178820 | Paediatric kit for donor blood | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter | 144300 | Kit for donor blood, four-chamber | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter | 144310 | Kit for donor blood, five-chamber | ||||||||
| – | Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter | 144290 | Kit for donor blood, multi-chamber | ||||||||
| – | Polymeric containers for deep freezing (cryopreservation) of donor blood components | 145490 | Container for storage or cultivation of blood/tissues | ||||||||
| – | Polymer containers for deep freezing (cryopreservation) of donor blood components | 169870 | Sterile container for cryopreservation of IVD (in vitro diagnostics device) samples | ||||||||
| – | Devices for removal of leukocytes from donor blood and its components | ||||||||||
| – | Devices for removal of leukocytes from the donor blood plasma | 322610 | Plasma filter for apheresis systems | ||||||||
| – | Devices for removal of leukocytes from the donor blood plasma (bedside) | 322610 | Plasma filter for apheresis systems | ||||||||
| 3. | Consumables for artificial lung ventilation devices | 32.50.13.190 | 32.50.50.000 | 110230 | 151440 | 165230
173070 185610 185620 185630 185640 218750 275820 318730 324650 322250 327610 327640 |
Consumables for artificial lung ventilation devices – disposable, sterile medical products for use in conjunction with artificial lung ventilation devices intended for supply and removal of controlled gas mixtures | ||||
| Respiratory circuit for artificial lung ventilation devices | 275820 | Disposable anesthetic respiratory circuit | |||||||||
| Respiratory circuit for artificial lung ventilation devices | 185610 | Disposable respiratory circuit for artificial lung ventilation devices | |||||||||
| – | Respiratory filter for artificial lung ventilation devices | 218750 | Non-sterile heat/moisture exchanger/bacterial filter | ||||||||
| – | Respiratory filter for artificial lung ventilation devices | 324650 | Sterile heat/moisture exchanger/bacterial filter | ||||||||
| – | Respiratory filter for artificial lung ventilation devices | 318730 | Non-sterile disposable bacterial filter for medical gases | ||||||||
| – | Respiratory filter for artificial lung ventilation devices | 322250 | Sterile disposable bacterial filter for medical gases | ||||||||
| – | Humidifier for artificial lung ventilation devices | 173070 | Humidifier for respiratory mixtures without a heating element | ||||||||
| – | Connector/ adapter for artificial lung ventilation devices | 185640 | Adapter for artificial lung ventilation devices | ||||||||
| – | Connector/ adapter for artificial lung ventilation devices | 327640 | Sterile tube/mask connector for respiratory circuits | ||||||||
| – | Connector/ adapter for artificial lung ventilation devices | 165140 | Disposable connector for respiratory circuits | ||||||||
| – | Connector/ adapter for artificial lung ventilation devices | 151450 | Disposable Y-shaped connector for respiratory circuits | ||||||||
| – | Connector/ adapter for artificial lung ventilation devices | 327610 | Non-sterile disposable tube/mask connector for respiratory circuits | ||||||||
| – | Water trap for artificial lung ventilation devices | 185620 | Disposable water trap for artificial lung ventilation devices | ||||||||
| 4. | Consumables for donor plasmapheresis/ thrombocytopheresis devices | 32.50.13.190 | 32.50.50.000 | Consumables for donor plasmapheresis/ thrombocytopheresis devices – disposable sterile medical products for use in conjunction with apheresis devices during the harvesting of donor plasma, platelet pools, and stem cells | |||||||
| – | Set/kit of consumables for harvesting plasma using the high-speed centrifugation method (HS technology) | ||||||||||
| – | Set/kit of consumables for harvesting plasma using the method of crossflow filtration on a rotating membrane filter | ||||||||||
| – | Tank for donor plasmapheresis devices | ||||||||||
| – | Container with ACD-A anticoagulant for donor plasmapheresis devices | 145450 | Solution for preservation of blood containing anticoagulant | ||||||||
| – | Container with sodium citrate 4% anticoagulant for donor plasmapheresis devices | 145450 | Solution for blood preservation containing anticoagulant | ||||||||
| – | Set of containers for donor plasmapheresis devices | Set of containers for donor plasmapheresis devices, single-chamber | |||||||||
| – | Set of containers for donor plasmapheresis devices | Set of containers for donor plasmapheresis devices, dual-chamber | |||||||||
| – | Set of containers for donor plasmapheresis devices | Set of containers for donor plasmapheresis devices, triple-chamber | |||||||||
| – | Set of lines for donor plasmapheresis devices | 262870 | Set of tubes for apheresis systems | ||||||||
| – | Kit/set of consumables for donor plasmapheresis devices | ||||||||||
| – | Container with anticoagulant for donor thrombocytopheresis devices | 145450 | Solution for blood preservation containing anticoagulant | ||||||||
| 5. | Consumables for artificial (extracorporeal) blood circulation devices | 32.50.13.190 | 32.50.50.000 | 111480 | 115570 | 115610
131520 191470 191560 191600 191610 191680 191770 191800 228290 228320 235170 331910 332960 |
Consumables for artificial blood circulation devices (ABCD) – disposable, sterile medical products for use in conjunction with artificial blood circulation devices for temporary, complete or partial replacement for the pumping function of the heart if the latter cannot be performed by the relevant bodily organ. | ||||
| – | Kit/set of consumables for artificial blood circulation devices | ||||||||||
| – | Set (oxygenator + lines) for artificial blood circulation devices | ||||||||||
| – | Oxygenator for artificial blood circulation devices | 115610 | Extracorporeal membrane oxygenator | ||||||||
| – | Oxygenator for artificial blood circulation devices | 115570 | Extracorporeal bubble oxygenator | ||||||||
| – | Oxygenator for artificial blood circulation devices | 131520 | Intravascular membrane oxygenator | ||||||||
| – | Reinforced (armoured) arterial cannula for artificial blood circulation devices | 191600 | Arterial cannula for artificial blood circulation | ||||||||
| – | Reinforced (armoured) paediatric arterial cannula for artificial blood circulation devices | 331910 | Paediatric cannula for artificial blood circulation | ||||||||
| – | Femoral arterial cannula for artificial blood circulation devices | 191610 | Femoral cannula for artificial blood circulation | ||||||||
| – | Femoral arterial cannula for artificial blood circulation devices | 111480 | Aortic cannula | ||||||||
| – | Arterial cannula for artificial blood circulation devices | 191470 | Cannula for cardioplegic solution | ||||||||
| – | Arterial cannula for artificial blood circulation devices | 228290 | Cannula for coronary arteries | ||||||||
| – | Arterial cannula for artificial blood circulation devices | 228320 | Cannula for coronary sinuses | ||||||||
| – | Femoral venous cannula for artificial blood circulation devices | 191610 | Femoral cannula for artificial blood circulation | ||||||||
| – | Bicaval femoral venous cannula for artificial blood circulation devices | 191680 | Venous cannula for artificial blood circulation | ||||||||
| – | Venous cannula for artificial blood circulation devices | 298290 | Transseptal cannula for artificial blood circulation systems | ||||||||
| – | Angle-adjustable venous cannula for artificial blood circulation devices | ||||||||||
| – | Haemoconcentrator for artificial blood circulation devices | 235170 | Haemoconcentrator | ||||||||
| – | Drainage/ suction for artificial blood circulation devices | ||||||||||
| – | Set of lines for artificial blood circulation devices | 191560 | Set of lines for artificial blood circulation systems | ||||||||
| – | Set of lines for artificial blood circulation devices | 191800 | Set of lines for initial filling of artificial blood circulation systems | ||||||||
| – | Set of lines for artificial blood circulation devices | 332960 | Connector for tubes for artificial blood circulation systems | ||||||||
| – | Pump/ pump head for artificial blood circulation devices | 191770 | Centrifugal pump for artificial blood circulation systems | ||||||||
| 6. | Urinals and colostomy bags | 152440 | 152450 | 152460
152470 156370 156410 156420 200040 221840 221850 255030 |
|||||||
| – | Single-component colostomy bag | 32.50.13.190 | 32.50.13.110 | 152450 | Single-component closed colostomy bags | Colostomy bags for rehabilitation of patients with abnormalities in faeces excretory function with specific diagnoses after surgeries, for use with colostomy, if applicable. Urinals for rehabilitation of patients with abnormalities in the natural outflow of urine after surgeries, for use with cytostome, if applicable. | |||||
| – | Single-component colostomy bag | 156410 | Single-component drainable colostomy bag for intestinal stoma | ||||||||
| – | Dual-component colostomy bag (ready for use) | 156420 | Open-type multicomponent colostomy bag for intestinal stoma | ||||||||
| – | Dual-component colostomy bag (ready for use) | 152460 | Multicomponent closed colostomy bag for colostomy | ||||||||
| – | Dual-component colostomy bag (ready for use) | ||||||||||
| – | Pouch for colostomy bags | ||||||||||
| – | Base plate for colostomy bags | 221840 | Convex base plate for colostomy bags | ||||||||
| – | Base plate for colostomy bags | 221850 | Flat base plate for colostomy bags | ||||||||
| – | Single-component urinal | 255030 | Single-component urological bag | ||||||||
| – | Dual-component urinal | 200040 | Multicomponent urological bag | ||||||||
| – | Urinal pouch | 152470 | Sterile closed non-portable urinal | ||||||||
| – | Urinal pouch | 152440 | Non-sterile closed portable urinal | ||||||||
| – | Urinal pouch | 156370 | Sterile urinal with a flush valve (non-wearable) | ||||||||