Identity
- Trade Name
- Spike Tube Set Adapter FDA UDI
- Generic Name
- Blood transfer set FDA UDI
- Device Name
- One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps, case of 20 FDA UDI
- Model / Reference
- S-FFP12 FDA UDI
- Description
- One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps, case of 20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816203021905 FDA UDI
- FDA Product Code
- KJG FDA UDI
- GMDN Term
- Blood transfer set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood transfer set
Spike Tube Set Adapter by OriGen Biomedical, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood transfer set.
- SteriPath Gen2, 23G, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
- Rem Systems — CODAN US Corporation · Class II
- Trima Accel — Terumo BCT, Inc.. · Class II
- Spectra Optia® — Terumo BCT, Inc.. · Class II
- SteriPath Gen2, 21G, 10ml — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
- Steripath Micro — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
- Trima Accel® — Terumo BCT, Inc.. · Class II
- SteriPath Gen2, Luer, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OriGen Biomedical, Inc.
Sources (2)
- FDA UDI 640dc04d-7a95-448d-bf58-8fff6121e865 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026