PureLife+ Sterilization Pouches 1192001

GUDID D79011920010

PureLife+ Sterilization Pouches, 2 1/4" x 4", Self-sealing sterilization pouches, Class 4 dual indicators, Thumb notch for easy opening

PURELIFE, LLC

Sterilization container liner

• Primary Device ID: D79011920010
• NIH Device Record Key: 2edfbb2a-704f-4e47-a1d5-406bdfa07f12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureLife+ Sterilization Pouches
• Version Model Number: 1192001
• Catalog Number: 1192001
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79011920010 [Unit of Use]
HIBCC	D79011920011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172280

FDA Product Code

• FRG: Wrap, sterilization

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: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [PureLife+ Sterilization Pouches]

• D79011920050: PureLife+ Sterilization Pouches, 5 1/4" x 10", Self-sealing sterilization pouches, Class 4 dual
• D79011920040: PureLife+ Sterilization Pouches, 3 1/2" x 9", Self-sealing sterilization pouches, Class 4 dual i
• D79011920030: PureLife+ Sterilization Pouches, 3 1/2" x 5 1/4", Self-sealing sterilization pouches, Class 4 du
• D79011920020: PureLife+ Sterilization Pouches, 2 3/4" x 9", Self-sealing sterilization pouches, Class 4 dual i
• D79011920010: PureLife+ Sterilization Pouches, 2 1/4" x 4", Self-sealing sterilization pouches, Class 4 dual i