AccessGUDID - DEVICE: MEDICOM SAFEMASK (10686864010248)

GUDID

Device Identifier (DI) Information

Brand Name: MEDICOM SAFEMASK
Version or Model: 2021
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2021
Company Name: AMD Medicom Inc

Primary DI Number: 10686864010248
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2024
Device Count: 50
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: SAFEMASK CONE ALUMINIUM NOSE PINK

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
FXX	Mask, surgical

FDA Premarket Submission

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

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
Storage Environment Temperature: less than 40 Degrees Celsius
Storage Environment Temperature: less than 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e81c0d8-1682-4da0-8ced-056c7c6904a1
Public Version Date: February 02, 2024
Public Version Number: 7
DI Record Publish Date: September 15, 2016