AccessGUDID - DEVICE: I-MED KN95 Respirator Mask (00622554052009)

GUDID

Device Identifier (DI) Information

Brand Name: I-MED KN95 Respirator Mask
Version or Model: 5200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5200
Company Name: I-Med Pharma Inc

Primary DI Number: 00622554052009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 249008772 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35177	Surgical/medical face mask, single-use	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
QLB	Decontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles
QLA	Decontamination systems for facemasks, surgical masks, face shields, and safety glasses
QKR	Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ded4ba4-a067-48de-aa23-8596a099280b
Public Version Date: October 05, 2022
Public Version Number: 2
DI Record Publish Date: June 18, 2020