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Anticoagulant Connection Adapter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 11221Model Anticoagulant Connection Adaptor
Identity
- Trade Name
- Spectra Optia™ Anticoagulant Adaptor EUDAMEDAnticoagulant Connection Adapter FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- Anticoagulant Connection Adapter FDA UDI
- Model / Reference
- 11221 EUDAMEDFDA UDIAnticoagulant Connection Adaptor EUDAMED
- Description
- Anticoagulant Connection Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05020583112216 EUDAMEDFDA UDI
- Basic UDI-DI
- 5020583ACAdapterPG EUDAMED
- FDA Product Code
- GKT FDA UDI
- EMDN Code
- B030199 APHERESIS COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Apheresis system tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Market of Registration
- Belgium EUDAMED
- 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
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 system tubing set
Anticoagulant Connection Adapter by Terumo BCT, Inc.. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 5fbc245f-8e73-490c-a086-8d279905c49f 35 fields · synced Jul 12, 2026
- EUDAMED 8c3aa2a4-2256-40ca-9223-85dfb9a425ff 61 fields · synced Jul 12, 2026