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Cook Spectrum

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Cook Spectrum FDA UDI
Generic Name
Centrally-inserted central venous catheter FDA UDI
Device Name
Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated 5 Lumen Polyurethane FDA UDI
Model / Reference
G43130 FDA UDI
Description
Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated 5 Lumen Polyurethane FDA UDI

Identifiers

Catalog Number
C-UQLM-1001J-RSC-ABRM FDA UDI
Primary DI / UDI-DI
00827002431300 FDA UDI
FDA Product Code
FOZ FDA UDI
GMDN Term
Centrally-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

Yes

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

Yes

FDA UDI

Category: Centrally-inserted central venous catheter

Cook Spectrum by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Centrally-inserted central venous catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 5b190c7d-1781-4c42-a6c2-cc309587d651 36 fields · synced Jun 8, 2026