Identity
- Trade Name
- TubeSet Adapter FDA UDI
- Generic Name
- Blood transfer set FDA UDI
- Device Name
- Two male luers to one female luer with 17cm of DMSO resistant tubing FDA UDI
- Model / Reference
- 2M-F17 FDA UDI
- Description
- Two male luers to one female luer with 17cm of DMSO resistant tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816203020595 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
TubeSet Adapter by OriGen Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OriGen Biomedical, Inc.
Sources (1)
- FDA UDI 12d8b6f9-b7d5-45b1-8b0e-bb3945ff1e07 35 fields · synced May 31, 2026