AccessGUDID - DEVICE: KIMBERLY-CLARK® PFR95™ N95 Particulate Filter Respirator and Surgical Mask (00036000623550)

GUDID

Device Identifier (DI) Information

Brand Name: KIMBERLY-CLARK® PFR95™ N95 Particulate Filter Respirator and Surgical Mask
Version or Model: 62355
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KIMBERLY-CLARK GLOBAL SALES, LLC

Primary DI Number: 00036000623550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 830997032 *Terms of Use

Device Description: N95 Particulate Filter Respirator and Surgical 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?
35177	Surgical/medical face mask, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.	Obsolete	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
Handling Environment Temperature: between 20 and 25 Degrees Celsius
Special Storage Condition, Specify: Protect from sources of light and radiation; Protect from moisture.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31ed0043-3e0d-44be-92c7-b5f691a15c54
Public Version Date: May 06, 2020
Public Version Number: 3
DI Record Publish Date: November 30, 2016