PeelVue Pro

GUDID 10615375010331

Self-Sealing Sterilization Pouches

Kerr Corporation

Sterilization packaging, single-use

• Primary Device ID: 10615375010331
• NIH Device Record Key: d11c4b74-3ce0-48b6-9b13-663bf50014a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeelVue Pro
• Version Model Number: 37064
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-597-7123
• Email: KerrCustCare@kavokerr.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient room temperature. Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615375010334 [Unit of Use]
GS1	10615375010331 [Primary]
GS1	20615375010338 [Package]; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162258

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-07-01

On-Brand Devices [PeelVue Pro ]

• 10615375010331: Self-Sealing Sterilization Pouches
• 10615375010324: Self-Sealing Sterilization Pouches
• 10615375010317: Self-Sealing Sterilization Pouches
• 10615375010300: Self-Sealing Sterilization Pouches
• 10615375010294: Self-Sealing Sterilization Pouches
• 10615375010287: Self-Sealing Sterilization Pouches
• 10615375010270: Self-Sealing Sterilization Pouches
• 10615375010263: Self-Sealing Sterilization Pouches
• 10615375010256: Self-Sealing Sterilization Pouches
• 10615375010249: Self-Sealing Sterilization Pouches
• 10615375010232: Self-Sealing Sterilization Pouches
• 10615375010225: Self-Sealing Sterilization Pouches
• 00615375011812: Self-Sealing Sterilization Pouches (Case has a different SKU number, i.e. 37151)