PureLife N95 1154801

GUDID D79011548013

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

PURELIFE, LLC

Surgical/medical respirator, non-antimicrobial, single-use
Primary Device IDD79011548013
NIH Device Record Keyeb62ae87-5bd8-4ef3-be32-a6e82dc2a787
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureLife N95
Version Model Number1154801
Catalog Number1154801
Company DUNS828690904
Company NamePURELIFE, LLC
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79011548010 [Unit of Use]
HIBCCD79011548011 [Primary]
HIBCCD79011548013 [Package]
Contains: D79011548011
Package: Case [240 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSHRespirator, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-22
Device Publish Date2021-06-14

Devices Manufactured by PURELIFE, LLC

D79010201010 - PureSkin2023-10-02 PureSkin Latex Powder-Free, X-Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
D79010201020 - PureSkin2023-10-02 PureSkin Latex Powder-Free, Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
D79010201030 - PureSkin2023-10-02 PureSkin Latex Powder-Free, Medium, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
D79010201040 - PureSkin2023-10-02 PureSkin Latex Powder-Free, Large, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
D79010201050 - PureSkin2023-10-02 PureSkin Latex Powder-Free, X-Large, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
D79010217010 - PureBliss2023-10-02 PureBliss Latex Powder-Free, X-Small, PureLife donates a portion of the proceeds from the sale of this glove to health and envir
D79010217020 - PureBliss2023-10-02 PureBliss Latex Powder-Free, Small, PureLife donates a portion of the proceeds from the sale of this glove to health and environ
D79010217030 - PureBliss2023-10-02 PureBliss Latex Powder-Free, Medium, PureLife donates a portion of the proceeds from the sale of this glove to health and enviro
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.