FDA.reportPublic FDA data

Familex Face Mask

Primary DI
89385048060900
Brand
Familex Face Mask
Company
PHU BAO GROUP COMPANY LIMITED
Model
Yellow
Device description
• 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 170mm x 90mm (± 5 mm) • Non - sterile, single use • Color Yellow • 50 masks pack in one box • Box dimensions: 185x105x90mm
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08938504806090PrimaryGS10
89385048060900Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08938504806090089385048060908938504806090
8938504806090089385048060900

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
555240671
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885914997567DRY PAD"36"" x 57"" (91.4cm x 144.8cm), 5/PK"2026-03-17
00885914997604DRY PAD"30"" x 36” (76.2cm x 91.4cm), 5/PK"2026-03-17
08859149975678DRY PAD36" x 57" (91.4cm x 144.8cm), 5/PK2026-03-17
00885914997581DRY PAD"23"" x 36"" (58.4cm x 91.4cm), 10/PK"2026-03-17
08859149976040DRY PAD30" x 36” (76.2cm x 91.4cm), 5/PK2026-03-17
08938504806793Pinnakle Moderate Underpad502025-05-30
08938504806816Perfetta Ultra Face MaskWhite individual packed, 35pcs2020-11-17
08938504806823Perfetta Ultra Face MaskBlue, 50pcs2020-11-17
08938504806649Perfetta Ultra Face MaskBlue individual packed, 35pcs2020-06-25
08938504806786Perfetta Ultra Face MaskWhite, 50pcs2020-06-25
08938504806045Familex Face MaskWhite2020-08-10
08938504806069Familex Face MaskBlue2020-08-10
08938504806076Perfetta Face MaskGreen2020-08-10
08938504806083Familex Face MaskPink2020-08-10
08938504806090Familex Face MaskYellow2020-08-10
89385048060450Familex Face MaskWhite2020-08-10
89385048060696Familex Face MaskBlue2020-08-10
89385048060764Perfetta Face MaskGreen2020-08-10
89385048060832Familex Face MaskPink2020-08-10
08938504806052Perfetta Face MaskModerate Green2020-06-30

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Primary DI, Brand, Company table
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00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
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00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
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