I-MED Surgical Mask 5100

GUDID 00622554055017

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

I-Med Pharma Inc

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use
Primary Device ID00622554055017
NIH Device Record Key4cce8307-6f1f-422f-96b9-f5ed62702816
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-MED Surgical Mask
Version Model Number5100
Catalog Number5100
Company DUNS249008772
Company NameI-Med Pharma Inc
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com
Phone+1(514)758-9998
Emaililan@imedpharma.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100622554051002 [Primary]
GS100622554055017 [Unit of Use]

FDA Product Code

QKRFace mask (except N95 respirator) for general public/healthcare personnel per IIE guidance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-10-05
Device Publish Date2020-06-18

Devices Manufactured by I-Med Pharma Inc

00622554050012 - I-MED Nitrile Powder-Free and Latex-Free Gloves2022-10-05 The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibly soft while providing excellent chemical resist
00622554055017 - I-MED Surgical Mask2022-10-05Mask 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
00622554055017 - I-MED Surgical Mask2022-10-05 Mask intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from tra
00622554052016 - I-MED KN95 Respirator Mask2022-10-05 Mini-fiber, high electrostatic filter, filtration efficiency of dust & powder above 95%. Continually repels contamination of blo
00622554051019 - I-MED Protective Isolation Gown2022-10-05 The I-MED Protective Isolation Gowns provide anti-bacterial protection with a comfortable fit. The I-MED Protective Isolation Go
00622554008907 - I-RELIEF Hot and Cold Therapy Eye Mask2021-09-20 Hot & Cold Therapy Eye Mask with ThermaBeadsTM for the relief of symptoms associated with Blepharitis, Dry Eye Disease, Meibomia
00622554057004 - I-MED Non-Contact Infrared digital Clinical Thermometer2020-12-04 Ideal for quickly detecting elevated body temperature using a non-contact design. Measures body temperature from 90°F to 109°F
00622554054010 - I-MED Protective Facshield2020-07-15 The I-MED Protective Faceshield is a one-time-use face protection shield. It protects against splatter and airborne particles wi

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.