I-MED KN95 Respirator Mask

Primary DI
00622554052016
Brand
I-MED KN95 Respirator Mask
Company
I-Med Pharma Inc
Model
5200
Catalog number
5200
Device description
Mini-fiber, high electrostatic filter, filtration efficiency of dust & powder above 95%. Continually repels contamination of blood and saliva. Inner cover sweat absorbant with water resistant outer cover. Low breathing resistance and high filtration efficiency.
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QLBDecontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLBDecontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00622554052009PrimaryGS10
00622554052016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00622554052009006225540520096225540520090622554052009
00622554052016006225540520166225540520160622554052016

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

Contacts#

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

Regulatory Flags#

DUNS number
249008772
Device count
20
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00622554051002I-MED Surgical Mask510051002020-06-18
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
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
00622554050005I-MED Nitrile Powder-Free and Latex-Free GlovesI-Med Pharma IncQLB2020-06-18
00622554052009I-MED KN95 Respirator MaskI-Med Pharma IncQLB2020-06-18
00622554053006I-MED Single Use Face MaskI-Med Pharma IncQLB2020-06-18