PureLife+ Barrier Film 1084502

GUDID D79010845020

PureLife+ Barrier Film, Blue, 4"x 6" sheets, Available in clear or blue

PURELIFE, LLC

Medical equipment drape, single-use

• Primary Device ID: D79010845020
• NIH Device Record Key: d5765791-3a9e-400f-9eba-96ed2fd613d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureLife+ Barrier Film
• Version Model Number: 1084502
• Catalog Number: 1084502
• Company DUNS: 828690904
• Company Name: PURELIFE, LLC
• Device Count: 1200
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79010845020 [Unit of Use]
HIBCC	D79010845021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190484

FDA Product Code

• NRD: Unit, operative dental, accessories

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: 2023-06-16
• Device Publish Date: 2023-06-08

On-Brand Devices [PureLife+ Barrier Film]

• D79010845020: PureLife+ Barrier Film, Blue, 4"x 6" sheets, Available in clear or blue
• D79010845010: PureLife+ Barrier Film, Clear, 4"x 6" sheets, Available in clear or blue