PureLife Dental 1190105

GUDID D79011901053

5 1/4" x 10" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink

PURELIFE, LLC

Sterilization packaging, single-use

• Primary Device ID: D79011901053
• NIH Device Record Key: 2d1cfcec-0b76-4f6a-ac86-9357a0296726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureLife Dental
• Version Model Number: 1190105
• Catalog Number: 1190105
• Company DUNS: 828690904
• Company Name: PURELIFE, LLC
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: 877-777-3303
• Email: sales@purelifedental.com
• Phone: 877-777-3303
• Email: sales@purelifedental.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79011901050 [Unit of Use]
HIBCC	D79011901051 [Primary]
HIBCC	D79011901053 [Package]; Contains: D79011901051; Package: Case [2000 Units]; In Commercial Distribution

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-24
• Device Publish Date: 2017-03-17

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