Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Umbilical catheter FDA UDI
- Device Name
- Polyurethane Umbilical Vessel Catheter,Single Lumen FDA UDI
- Model / Reference
- 8888160341 FDA UDI
- Description
- Polyurethane Umbilical Vessel Catheter,Single Lumen FDA UDI
Identifiers
- Catalog Number
- 8888160341 FDA UDI
- Primary DI / UDI-DI
- 20884527005120 FDA UDI
- FDA Product Code
- FOS FDA UDI
- GMDN Term
- Umbilical catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
- Total Volume — .33 Milliliter FDA UDILength — 9.80 Inch FDA UDICatheter Gauge — 5 French FDA UDI
Category: Umbilical catheter
Argyle by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Umbilical catheter.
- UMBILI-CATH — Utah Medical Products, Inc. · Class II
- VYGON — Vygon Corp. · Class II
- Argyle — Cardinal Health 200, LLC · Class II
- UMBILI-CATH — Utah Medical Products, Inc. · Class II
- VYGON — Vygon Corp. · Class II
- UMBILI-CATH — Utah Medical Products, Inc. · Class II
- VYGON — Vygon Corp. · Class II
- UMBILI-CATH — Utah Medical Products, Inc. · Class II
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
- Cardinalhealth
Sources (1)
- FDA UDI a9686072-bcc8-4d89-9915-0ff3e60b2d4d 37 fields · synced May 30, 2026