Identity
- Trade Name
- Spike Adapter FDA UDI
- Generic Name
- Blood transfer set FDA UDI
- Device Name
- One spike to one male luer with 150cm tubing and roller clamp FDA UDI
- Model / Reference
- 150-S-M FDA UDI
- Description
- One spike to one male luer with 150cm tubing and roller clamp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816203020588 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
- Not 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
Spike Adapter by OriGen Biomedical, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- OriGen Biomedical, Inc.
Sources (2)
- FDA UDI 208c42f3-2345-4a07-8154-709033d19ac4 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026