Identity
- Trade Name
- Autosoft30™ FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- Single use infusion tubing for subcutaneous infusion. The infusion tubing must be used as described in the instruction for use. FDA UDI
- Model / Reference
- 1000202 FDA UDI
- Description
- Single use infusion tubing for subcutaneous infusion. The infusion tubing must be used as described in the instruction for use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05705244014633 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 — 110 Centimeter FDA UDIDepth — 13 Millimeter FDA UDIAngle — 30 degree FDA UDI
Autosoft30™ 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 |
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Manufacturer
- Manufacturer
- Unomedical A/S
Sources (1)
- FDA UDI 9c313780-79d5-4ede-8291-15ebbf185d09 37 fields · synced Jun 8, 2026