AccessGUDID - DEVICE: Zhou Medical N95 Respirator Mask (B820Z1201010)

GUDID

Device Identifier (DI) Information

Brand Name: Zhou Medical N95 Respirator Mask
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z120101
Company Name: ZHOU MEDICAL SOLUTIONS LLC

Primary DI Number: B820Z1201010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 081373840 *Terms of Use

Device Description: Zhou Medical N95 NIOSH Respirator Mask

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):	No
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: Yes
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: 08b2d310-c0e9-4cf6-b128-33525cf5e2de
Public Version Date: September 13, 2023
Public Version Number: 4
DI Record Publish Date: December 11, 2019