Identity
- Trade Name
- Cook TPN FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- Cook TPN, Double Lumen Catheter Set With 5.5Fr Peel-Away, Introducer Set FDA UDI
- Model / Reference
- G08065 FDA UDI
- Description
- Cook TPN, Double Lumen Catheter Set With 5.5Fr Peel-Away, Introducer Set FDA UDI
Identifiers
- Catalog Number
- C-TPNS-5.0D-65-12-LPC FDA UDI
- Primary DI / UDI-DI
- 00827002080652 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Peripherally-inserted central venous 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Peripherally-inserted central venous catheter
Cook TPN by Cook Incorporated — Class II — 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI f8c12a09-8fc4-4531-bdf0-4c350e37ace2 36 fields · synced Jun 8, 2026