Identity
- Trade Name
- 3ml Syringe, FLL X SCD FDA UDI
- Generic Name
- Blood transfer set FDA UDI
- Device Name
- 3ml BD syringe on a female luer with 15cm of SCD tubing FDA UDI
- Model / Reference
- 15-R3FT FDA UDI
- Description
- 3ml BD syringe on a female luer with 15cm of SCD tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816203020564 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
3ml Syringe, FLL X SCD by OriGen Biomedical, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 fc066b63-12cd-42d2-9dbf-ac24f4bd8c62 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026