Identity
- Trade Name
- Accessory Set FDA UDI
- Generic Name
- Venous butterfly needle/set FDA UDI
- Model / Reference
- BCA-SET3-U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640138981432 FDA UDI
- GMDN Term
- Venous butterfly needle/set FDA UDI
Classification
- 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
Yes
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: Venous butterfly needle/set
Accessory Set by Regen Lab Sa — 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 | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Regen Lab Sa
Sources (2)
- FDA UDI f286fc8d-f4e0-477e-9ae4-fadc668f1a70 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026