AccessGUDID - DEVICE: PureLife Dental (D79011501021)

GUDID

Device Identifier (DI) Information

Brand Name: PureLife Dental
Version or Model: 1150102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1150102
Company Name: PURELIFE, LLC

Primary DI Number: D79011501021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 828690904 *Terms of Use

Device Description: Pink Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex-free ear loops, Metal nose piece

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
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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Cool dry place
Storage Environment Temperature: less than 40 Degrees Celsius
Storage Environment Temperature: less than 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7edbeddc-5130-448e-9f3f-5fb94a1297dd
Public Version Date: March 08, 2021
Public Version Number: 6
DI Record Publish Date: March 17, 2017