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Rika Plasma Bottle
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 21300Model Rika Plasma Bottle
Identity
- Trade Name
- Rika Plasma Bottle EUDAMEDFDA UDI
- Generic Name
- Apheresis kit FDA UDI
- Device Name
- elabeling.terumobct.com FDA UDI
- Model / Reference
- 21300 EUDAMEDFDA UDIRika Plasma Bottle EUDAMED
- Description
- elabeling.terumobct.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05020583213005 EUDAMEDFDA UDI
- Basic UDI-DI
- 5020583RikaBotPL EUDAMED
- FDA Product Code
- GKT FDA UDI
- EMDN Code
- B030199 APHERESIS COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Apheresis kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Apheresis kit
Rika Plasma Bottle by Terumo BCT, Inc.. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Apheresis kit.
- PowerFlow, ChronoFlex — Bard Access Systems, Inc. · Class II
- PowerFlow — Bard Access Systems, Inc. · Class II
- H.E.L.P.® — B.Braun Avitum AG · Class III
- PowerFlow — Bard Access Systems, Inc. · Class II
- B.BRAUN — B.Braun Avitum AG · Class III
- Rika Plasma Separation Set — Terumo BCT, Inc.. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Terumo BCT, Inc..
Sources (2)
- FDA UDI b8bb2410-114f-4d2c-8286-edb46046b9e1 35 fields · synced Jun 19, 2026
- EUDAMED 2e895fb5-3b80-4421-a4c7-e5d33722daf6 61 fields · synced Jun 19, 2026