Identity
- Trade Name
- Unistik FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- Unistik Luer Adapter, Multi sample luer adapter FDA UDI
- Model / Reference
- BC 7905 FDA UDI
- Description
- Unistik Luer Adapter, Multi sample luer adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00384707905012 FDA UDI
- 510(k) Number
- K223854 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood collection set, invasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood collection set, invasive
Unistik by Owen Mumford Usa Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223854 also covers:
- Unistik — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
- Unistik ShieldLock — OWEN MUMFORD USA INCORPORATED
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 II | Pending data |
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Manufacturer
- Manufacturer
- Owen Mumford Usa Incorporated
Sources (1)
- FDA UDI 9aef332f-8e43-4a49-b237-0756a78bda11 34 fields · synced Jun 6, 2026