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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
Patient gown, single-use FDA UDI
Device Name
HALYARD* Tri-Layer Over-the-Head Isolation Gowns, Universal, Yellow, 11" x 5.5" Fold FDA UDI
Model / Reference
32574 FDA UDI
Description
HALYARD* Tri-Layer Over-the-Head Isolation Gowns, Universal, Yellow, 11" x 5.5" Fold FDA UDI

Identifiers

Catalog Number
32574 FDA UDI
Primary DI / UDI-DI
20680651325741 FDA UDI
FDA Product Code
OEA FDA UDI
GMDN Term
Patient gown, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 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

No

FDA UDI

Category: Patient gown, single-use

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

Similar devices

Also classified as Patient gown, single-use.

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 0cd38d08-9a13-412a-a85a-56e53c97db63 35 fields · synced May 30, 2026