AccessGUDID - DEVICE: PureLife N95 (D79011548011)

GUDID

Device Identifier (DI) Information

Brand Name: PureLife N95
Version or Model: 1154801
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1154801
Company Name: PURELIFE, LLC

Primary DI Number: D79011548011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 828690904 *Terms of Use

Device Description: PureLife N95 Respirator, Disposable N95, Niosh approved N95 respirator, Headband-style, surgical respirator, Electrostatically-charged filter media provides low breathing resistance, Latex-free, staple-free head straps for comfort and safety, Soft foam nose cushion

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
MSH	Respirator, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061375	000

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
Storage Environment Temperature: less than 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb62ae87-5bd8-4ef3-be32-a6e82dc2a787
Public Version Date: September 13, 2023
Public Version Number: 3
DI Record Publish Date: June 14, 2021