Identity
- Trade Name
- Autosoft XC 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
- 1006922 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
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 05705244022386 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
- 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
- Angle — 90 degree FDA UDIDepth — 6 Millimeter FDA UDILength — 12 Centimeter FDA UDI
Category: Electric infusion pump administration set, single-use
Autosoft XC by Unomedical A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electric infusion pump administration set, single-use.
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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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Unomedical A/S
Sources (1)
- FDA UDI 49d74a5c-2749-4c80-a784-4bb75c46724b 37 fields · synced May 30, 2026