Rebuilder 99-28-155446

GUDID 10855683006668

Rebuilder Electrolyte 1 gallon

PARKER LABORATORIES INC

Electrode conductive medium

• Primary Device ID: 10855683006668
• NIH Device Record Key: 5ac67787-f75d-4bd6-a661-180a230614b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rebuilder
• Version Model Number: Rebuilder Electrolyte 1 gallon
• Catalog Number: 99-28-155446
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES INC
• Device Count: 1
• 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: false
• 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: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006661 [Primary]
GS1	10855683006668 [Package]; Contains: 00855683006661; Package: Inner [1 Units]; In Commercial Distribution
GS1	20855683006665 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780973

FDA Product Code

• GYB: Media, Electroconductive

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: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [Rebuilder]

• 10855683006668: Rebuilder Electrolyte 1 gallon
• 10855683006651: Rebuilder Electrolyte 250 ml Spray