PureLife Dental 1154902

GUDID D79011549023

PureLife Level 3 Masks Pink

PURELIFE, LLC

Surgical/medical face mask, single-use
Primary Device IDD79011549023
NIH Device Record Keydc86286a-3a16-4fc7-b891-ff1d9ae43e0c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureLife Dental
Version Model Number1154902
Catalog Number1154902
Company DUNS828690904
Company NamePURELIFE, LLC
Device Count50
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79011549020 [Unit of Use]
HIBCCD79011549021 [Primary]
HIBCCD79011549023 [Package]
Contains: D79011549021
Package: Case [500 Units]
In Commercial Distribution

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-10
Device Publish Date2020-08-01

On-Brand Devices [PureLife Dental]

D790119010535 1/4" x 10" Sterilization Pouches, Built-in color-changing internal and external process indica
D790119010433 1/2" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicat
D790119010333 1/2" x 5 1/4" Sterilization Pouches, Built-in color-changing internal and external process ind
D790119010232 3/4" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicat
D790119010132 1/4" x 4" Sterilization Pouches, Built-in color-changing internal and external process indicat
D79011501023Pink Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex
D79011501013Blue Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex
D790111030204" x 4" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
D790111030102" x 2" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
D79010811040Lilac "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
D79010811030Pink "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
D79010811020Blue "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
D79010811010White "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
D79011549023PureLife Level 3 Masks Pink
D79011549013PureLife Level 3 Masks Blue
D79011430023Clear/Blue Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comf
D79011430013White/White Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient com

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