INDALJIMTM

Primary DI
07506561200130
Brand
INDALJIMTM
Company
Indaljim, S.A. de C.V.
Model
C3C-01
Published
2022-01-28
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
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
07506561200130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506561200130075065612001307506561200130

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
812753058
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07506561200000INDALJIMTMBS25-M2022-01-28
07506561200017INDALJIMTMBS25-L2022-01-28
07506561200024INDALJIMTMBS25-XL2022-01-28
07506561200031INDALJIMTMBS35-M2022-01-28
07506561200048INDALJIMTMBS35-L2022-01-28
07506561200055INDALJIMTMBS35-XL2022-01-28
07506561200062INDALJIMTMGR-012022-01-28
07506561200215INDALJIMTMBMD-M2022-01-28
07506561200222INDALJIMTMBMD-L2022-01-28
07506561200239INDALJIMTMBMD-XL2022-01-28
07506561200246INDALJIMTMOV-M2022-01-28
07506561200253INDALJIMTMOV-L2022-01-28
07506561200260INDALJIMTMOV-XL2022-01-28
07506561200277INDALJIMTMBE-012022-01-28

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
088097834905253PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834905324PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
00816703025864MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13
00816703025871MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13