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Halyard

FDA UDI

Class I (US FDA UDI)

by O&M Halyard, Inc.

Identity

Trade Name
Halyard FDA UDI
Generic Name
Tourniquet cuff bandage, non-latex FDA UDI
Device Name
O.R. Tourniquet Cover, Large FDA UDI
Model / Reference
53605 FDA UDI
Description
O.R. Tourniquet Cover, Large FDA UDI

Identifiers

Catalog Number
53605 FDA UDI
Primary DI / UDI-DI
20680651536055 FDA UDI
FDA Product Code
IPM FDA UDI
GMDN Term
Tourniquet cuff bandage, non-latex FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tourniquet cuff bandage, non-latex

Halyard by O&M Halyard, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tourniquet cuff bandage, non-latex.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
O&M Halyard, Inc.

Sources (1)

  • FDA UDI 249e48ab-c8d5-4ea2-9979-e0a7ff979fde 35 fields · synced May 30, 2026