Identity
- Trade Name
- Varithena® Administration Pack FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Silicon-free Syringes, 1 Manometer Tube and 2 Compression pads) . The administration pack is not subject to a 510K as each of the components has clearance as a medical device via a 510K (Syringe and Manometer Tubing) or 510K exempt devices (Compression Pads, Varithena Transfer Unit). The Varithena® administration pack is provided with the Varithena® drug product pack to the customer. FDA UDI
- Model / Reference
- FP00024 FDA UDI
- Description
- The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Silicon-free Syringes, 1 Manometer Tube and 2 Compression pads) . The administration pack is not subject to a 510K as each of the components has clearance as a medical device via a 510K (Syringe and Manometer Tubing) or 510K exempt devices (Compression Pads, Varithena Transfer Unit). The Varithena® administration pack is provided with the Varithena® drug product pack to the customer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060116921328 FDA UDI
- GMDN Term
- Medication transfer 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: Medication transfer set
Varithena® Administration Pack by Biocompatibles Uk Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Biocompatibles Uk Ltd
Sources (1)
- FDA UDI 6103b42c-a252-4afb-a917-bc5bf967bc9c 34 fields · synced May 30, 2026