PureLife Dental 1150102

GUDID D79011501023

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

PURELIFE, LLC

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use
Primary Device IDD79011501023
NIH Device Record Key7edbeddc-5130-448e-9f3f-5fb94a1297dd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureLife Dental
Version Model Number1150102
Catalog Number1150102
Company DUNS828690904
Company NamePURELIFE, LLC
Device Count50
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 Datefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79011501020 [Unit of Use]
HIBCCD79011501021 [Primary]
HIBCCD79011501023 [Package]
Contains: D79011501021
Package: Case [500 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2017-03-17

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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