FDA.reportPublic FDA data

Perfetta Ultra Face Mask

Primary DI
08938504806823
Brand
Perfetta Ultra Face Mask
Company
PHU BAO GROUP COMPANY LIMITED
Model
Blue, 50pcs
Device description
4 Ply - Medical/ surgical Disposable High Filtration face maskNon- sterile, single useColor blue50 masks pack in one box
Published
2020-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MSHRespirator, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSHRespirator, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08938504806823PrimaryGS10
89385048068234Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08938504806823089385048068238938504806823
8938504806823489385048068234

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.

Regulatory Flags#

DUNS number
555240671
Device count
50
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
89385048060900Familex Face MaskYellow2020-08-10
08938504806052Perfetta Face MaskModerate Green2020-06-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860014697333RiskWise Health Kits RiskWise Supplies LLCMSH2026-05-18
10326053123457Regard™Resource Optimization & Innovation, L.L.C.MSH2026-03-18
00817169029649Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMSH2026-03-05
00860014697302RiskWise SuppliesRiskWise Supplies LLCMSH2026-02-17
00860014697319RiskWise Supplies RiskWise Supplies LLCMSH2026-02-17
20680651492993HalyardO&M HALYARD, INC.MSH2025-09-30
20680651493006HalyardO&M HALYARD, INC.MSH2025-09-30
00639890596333RadnorLOUIS M. GERSON CO.MSH2025-04-14
00764423027777FastlineLOUIS M. GERSON CO.MSH2025-04-14
00850019086157Altor SafetyLOUIS M. GERSON CO.MSH2025-04-14
00850052096427MedavaLOUIS M. GERSON CO.MSH2025-04-14
00044585817301FastlineLOUIS M. GERSON CO.MSH2025-04-14
10850019086154Altor SafetyLOUIS M. GERSON CO.MSH2025-04-14
00850052096434MedavaLOUIS M. GERSON CO.MSH2025-04-14
00781311086104SAS Safety / GersonBunzl USA Holdings LLCMSH2025-04-04
10016659570150All Pro Bunzl USA Holdings LLCMSH2025-04-04
00850017658288SHIELDLWS HEALTH & SAFETY LLCMSH2025-02-11
00850017658264Lighthouse Worldwide Solutions IncLighthouse Worldwide Solutions, Inc.MSH2025-02-11
00850056748070FORWARD Enforcement Group Medical BagINTEGRATED MEDCRAFT LLCMSH2024-10-04
00628678429024VitacoreVitacore Industries IncMSH2024-09-05
00628678429031VitacoreVitacore Industries IncMSH2024-09-05
20197344019530MedlineMEDLINE INDUSTRIES, INC.MSH2024-03-27
30197344019537MedlineMEDLINE INDUSTRIES, INC.MSH2024-03-27
00852212003696ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
10852212003693ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
16946276000010Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
06946276000013Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
00044585333016GERSONLOUIS M. GERSON CO.MSH2024-01-12
00044585833301GERSONLOUIS M. GERSON CO.MSH2024-01-12