Familex Face Mask

FDA UDI

Class I (US FDA UDI)

by Phu Bao Group Company Limited

Identity

Trade Name: Familex 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: 170mm x 90mm (± 5 mm) • Non - sterile, single use • Color White • 50 masks pack in one box • Box dimensions: 185x105x90mm FDA UDI
Model / Reference: White FDA UDI
Description: • 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 170mm x 90mm (± 5 mm) • Non - sterile, single use • Color White • 50 masks pack in one box • Box dimensions: 185x105x90mm FDA UDI

Identifiers

Primary DI / UDI-DI: 08938504806045 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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

Familex Face Mask by Phu Bao Group Company Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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hcs — DYAD MEDICAL SOURCING, LLC · Class I
Precept® — Precept Medical Products, Inc. · Class II
AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
Precept® — Precept Medical Products, Inc. · Class II
Precept® — Precept Medical Products, Inc. · Class II
Surgical Face Mask — Foshan Nanhai Plus Medical Co., Ltd · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Phu Bao Group Company Limited

Sources (1)

FDA UDI d06ffb5e-d1e5-4591-a64c-cfa90284b775 33 fields · synced May 30, 2026