AccessGUDID - DEVICE: A&Z Pharmaceutical (00850024750081)

GUDID

Device Identifier (DI) Information

Brand Name: A&Z Pharmaceutical
Version or Model: M8004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A & Z Pharmaceutical Inc.

Primary DI Number: 00850024750081
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 926820705 *Terms of Use

Device Description: The N95 Respirator is designed to help provide respiratory protection for the user. This product has a filter efficiency of 95% or greater against solid and liquid aerosols free of oil. This product contains no components made from natural rubber latex.

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 [?]
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
Special Storage Condition, Specify: Store in a cool, dry, clean place away from fire and contamination.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2053579c-4d7b-47f2-9c53-7b5a3423a774
Public Version Date: September 13, 2023
Public Version Number: 2
DI Record Publish Date: October 27, 2021