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Halyard

FDA UDI

Class II (US FDA UDI)

by O&M Halyard, Inc.

Identity

Trade Name
Halyard FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
Fluidshield* 3 Ported N95 Particulate Filter Respirator with SO SOFT* Lining, Orange, Regular Size FDA UDI
Model / Reference
99175 FDA UDI
Description
Fluidshield* 3 Ported N95 Particulate Filter Respirator with SO SOFT* Lining, Orange, Regular Size FDA UDI

Identifiers

Catalog Number
99175 FDA UDI
Primary DI / UDI-DI
30680651991752 FDA UDI
510(k) Number
K974068 FDA UDI
FDA Product Code
MSH FDA UDI
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical/medical face mask, non-antimicrobial, single-use

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

Similar devices

Also classified as Surgical/medical face mask, non-antimicrobial, single-use.

Cleared under the same submission

K974068 also covers:

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 2a35ef9d-2dc6-4acf-a982-9fe74ce56338 36 fields · synced May 30, 2026