FDA.reportPublic FDA data

3PLY SURGICAL MASK

Primary DI
08809783490525
Brand
3PLY SURGICAL MASK
Company
UNICO GLOBAL INC
Model
FM-EU2001
Published
2022-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QKRFace Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health Emergency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809783490624PrimaryGS10
08809783490525Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809783490624088097834906248809783490624
08809783490525088097834905258809783490525

GMDN Terms#

Term, Definition table
TermDefinition
Public face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; 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). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690513726
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
08809783490426SURGICAL MASKSA-2001SM2022-03-18
08809783490587Unico High Performance Surgical MaskSM-301E2022-03-18
08809783490594Unico High Performance Surgical MaskSM-301T2022-03-18
08809783490600Unico High Performance Surgical Mask With Face ShieldSM-301FS2022-03-18
08809783490617Unico High Performance Surgical Mask With Face ShieldSM-301FST2022-03-18
08809783490303DISPOSABLE NITRILE GLOVESA-2001NG2022-03-18
08809783490310FACE SHIELD MASKSA-2001FSM2022-03-18
08809783490327MEDICAL APRONSA-2001MA2022-03-18
08809783490402SURGICAL CAPSSA-2001CA2022-03-18
08809783490433SURGICAL MASK WITH FACE SHIELDSA-2001MFS2022-03-18
088097834906243PLY SURGICAL MASKFM-EU20012022-03-18
088097834906314PLY SURGICAL MASKFM-EU20022022-03-18
08809783490105Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-S2022-03-18
08809783490112Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-M2022-03-18
08809783490129Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-L2022-03-18
08809783490136Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-XL2022-03-18
08809783490143Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-XXL2022-03-18
08809783490150Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-S2022-03-18
08809783490167Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-M2022-03-18
08809783490174Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-L2022-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975089780010DISPOSABLE FACE MASKHubei Qifu Protective Products Co.,LtdQKR2025-12-23
00057475696009BIOS ProfessionalThermor LtdQKR2023-09-20
40841767107711Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-09-07
00841767107713Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-09-07
40841767107728Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-30
00841767107720Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-30
10841767106034Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106004Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106011Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106028Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106226Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106037Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106006Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106013Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106020Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106228Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
04007418891141Medical Face MaskHans Hepp GmbH & Co. KGQKR2023-07-28
04007418891158Medical Face MaskHans Hepp GmbH & Co. KGQKR2023-07-28
40841767107650Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-03-28
00841767107652Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-03-28
06974424843502LEBOOLeboo Healthcare Products LimitedQKR2023-03-21
00810084932094WeCareJeg & Sons Inc.QKR2022-12-16
00810084939314WeCareJeg & Sons Inc.QKR2022-12-16
06973509180006TongdaXiantao Tongda Non-Woven Products Co., Ltd.QKR2022-12-02
088097834906243PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834906314PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834905324PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
07506561200130INDALJIMTMIndaljim, S.A. de C.V.QKR2022-01-28
00816703025864MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13
00816703025871MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13