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Turbo-Flo HD

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Turbo-Flo HD FDA UDI
Generic Name
Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Device Name
Cook Turbo-Flo HD Hemodialysis Catheter Tray Double Lumen Polyurethane FDA UDI
Model / Reference
G35096 FDA UDI
Description
Cook Turbo-Flo HD Hemodialysis Catheter Tray Double Lumen Polyurethane FDA UDI

Identifiers

Catalog Number
C-HDCSYJ-1201J-LSC-IHI-CCT FDA UDI
Primary DI / UDI-DI
00827002350960 FDA UDI
FDA Product Code
MPB FDA UDI
GMDN Term
Double-lumen haemodialysis catheter, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5540 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

Yes

FDA UDI

Category: Double-lumen haemodialysis catheter, nonimplantable

Turbo-Flo HD by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double-lumen haemodialysis catheter, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI a72d0f77-ba2c-4305-b9d1-ea86e169df79 36 fields · synced Jun 8, 2026