AccessGUDID - DEVICE: MEDICOM SAFEMASK N95 (10686864033766)

GUDID

Device Identifier (DI) Information

Brand Name: MEDICOM SAFEMASK N95
Version or Model: M2321
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M2321
Company Name: AMD Medicom Inc

Primary DI Number: 10686864033766
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2024
Device Count: 20
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: SAFEMASK N95 CONE RESPIRATOR EARLOOP WHITE

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?
57794	Surgical/medical respirator, non-antimicrobial, single-use	A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSH	Respirator,surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020474	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Cool dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 11513bab-5f31-4dca-9d88-febf823fdadb
Public Version Date: February 02, 2024
Public Version Number: 8
DI Record Publish Date: September 15, 2016