FDA.reportPublic FDA data

I-MED Surgical Mask

Primary DI
00622554051002
Brand
I-MED Surgical Mask
Company
I-Med Pharma Inc
Model
5100
Catalog number
5100
Device description
Mask intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKRFace mask (except N95 respirator) for general public/healthcare personnel per IIE guidance

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
00622554051002PrimaryGS10
00622554055017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00622554051002006225540510026225540510020622554051002
00622554055017006225540550176225540550170622554055017

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.

Contacts#

Phone, Email table
PhoneEmail
+1(514)758-9998ilan@imedpharma.com

Regulatory Flags#

DUNS number
249008772
Device count
50
Premarket exempt
true
Lot or batch
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
00622554008907I-RELIEF Hot and Cold Therapy Eye Mask089008902020-06-18
00622554050005I-MED Nitrile Powder-Free and Latex-Free Gloves500050002020-06-18
00622554052009I-MED KN95 Respirator Mask520052002020-06-18
00622554053006I-MED Single Use Face Mask530053002020-06-18
00622554054003I-MED Protective Facshield540054002020-07-07
00622554055000I-MED Protective Isolation Gown550055002020-06-18
00622554050012I-MED Nitrile Powder-Free and Latex-Free Gloves500050002020-06-18
00622554055017I-MED Surgical Mask510051002020-06-18
00622554052016I-MED KN95 Respirator Mask520052002020-06-18
00622554051019I-MED Protective Isolation Gown550055002020-06-18
00622554057004I-MED Non-Contact Infrared digital Clinical Thermometer570057002020-06-18
00622554054010I-MED Protective Facshield540054002020-07-07

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
07506561200130INDALJIMTMIndaljim, S.A. de C.V.QKR2022-01-28
00816703025864MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13