Rebuilder 99-25-155446

GUDID 10855683006651

Rebuilder Electrolyte 250 ml Spray

PARKER LABORATORIES INC

Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium

• Primary Device ID: 10855683006651
• NIH Device Record Key: d1c4c388-ea34-4383-a37b-1b62fe82d90e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rebuilder
• Version Model Number: Rebuilder Electrolyte 250 ml Spray
• Catalog Number: 99-25-155446
• 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: 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: 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	00855683006654 [Primary]
GS1	10855683006651 [Package]; Contains: 00855683006654; Package: Inner [12 Units]; In Commercial Distribution
GS1	20855683006658 [Package]; Package: Case [6 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