PureLife Dental 1154902

GUDID D79011549023

PureLife Level 3 Masks Pink

PURELIFE, LLC

Surgical/medical face mask, single-use

• Primary Device ID: D79011549023
• NIH Device Record Key: dc86286a-3a16-4fc7-b891-ff1d9ae43e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureLife Dental
• Version Model Number: 1154902
• Catalog Number: 1154902
• Company DUNS: 828690904
• Company Name: PURELIFE, LLC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79011549020 [Unit of Use]
HIBCC	D79011549021 [Primary]
HIBCC	D79011549023 [Package]; Contains: D79011549021; Package: Case [500 Units]; In Commercial Distribution

FDA Product Code

• FXX: Mask, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-10
• Device Publish Date: 2020-08-01

On-Brand Devices [PureLife Dental]

• D79011901053: 5 1/4" x 10" Sterilization Pouches, Built-in color-changing internal and external process indica
• D79011901043: 3 1/2" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicat
• D79011901033: 3 1/2" x 5 1/4" Sterilization Pouches, Built-in color-changing internal and external process ind
• D79011901023: 2 3/4" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicat
• D79011901013: 2 1/4" x 4" Sterilization Pouches, Built-in color-changing internal and external process indicat
• D79011501023: Pink Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex
• D79011501013: Blue Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex
• D79011103020: 4" x 4" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
• D79011103010: 2" x 2" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
• D79010811040: Lilac "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
• D79010811030: Pink "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
• D79010811020: Blue "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
• D79010811010: White "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
• D79011549023: PureLife Level 3 Masks Pink
• D79011549013: PureLife Level 3 Masks Blue
• D79011430023: Clear/Blue Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comf
• D79011430013: White/White Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient com