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Cook

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Cook FDA UDI
Generic Name
In-line backflow valve, single-use FDA UDI
Device Name
Tuohy-Borst Adapter FDA UDI
Model / Reference
G18813 FDA UDI
Description
Tuohy-Borst Adapter FDA UDI

Identifiers

Catalog Number
TBAYR-6 FDA UDI
Primary DI / UDI-DI
00827002188136 FDA UDI
510(k) Number
K173105 FDA UDI
FDA Product Code
ODC FDA UDI
GMDN Term
In-line backflow valve, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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: In-line backflow valve, single-use

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

Similar devices

Also classified as In-line backflow valve, single-use.

Cleared under the same submission

K173105 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 4c1d52fa-ee9a-45c3-b1d3-fcbd732d67e2 37 fields · synced Jun 8, 2026