Identity
- Trade Name
- thalaset™ FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. FDA UDI
- Model / Reference
- 71-060-2738 FDA UDI
- Description
- Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05705244003576 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Centimeter FDA UDIDepth — 8 Millimeter FDA UDIAngle — 90 degree FDA UDI
thalaset™ by Unomedical A/S — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unomedical A/S
Sources (1)
- FDA UDI ad2583ca-dd8c-4cb9-8779-949584fe969f 36 fields · synced Jun 1, 2026