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Cusmed Face Mask

FDA UDI

Class I (US FDA UDI)

by Ossaware Biotech Co., Ltd.

Identity

Trade Name
CUSMED FACE MASK FDA UDI
Generic Name
Surgical/medical face mask, single-use FDA UDI
Device Name
3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 5 mm) • Non - sterile, single use FDA UDI
Model / Reference
9600.0000.00 FDA UDI
Description
3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 5 mm) • Non - sterile, single use FDA UDI

Identifiers

Primary DI / UDI-DI
04717002404380 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Surgical/medical face mask, 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical/medical face mask, single-use

Cusmed Face Mask by Ossaware Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ossaware Biotech Co., Ltd.

Sources (1)

  • FDA UDI 5ce5d6ac-50e1-4299-b39d-c55212a65190 34 fields · synced Jun 1, 2026