AccessGUDID - DEVICE: Crosstex International (10732224000524)

GUDID

Device Identifier (DI) Information

Brand Name: Crosstex International
Version or Model: GPRN95
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GPRN95
Company Name: CROSSTEX INTERNATIONAL, INC.

Primary DI Number: 10732224000524
Issuing Agency: GS1
Commercial Distribution End Date: January 17, 2025
Device Count: 28
Labeler D-U-N-S® Number*: 057728685 *Terms of Use

Device Description: Isolator Plus N95 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":	No
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
MSH	Respirator,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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b085fc74-964d-467f-a7f3-8d7a73e8733f
Public Version Date: January 20, 2025
Public Version Number: 8
DI Record Publish Date: October 13, 2016