Rebound KBTR6

GUDID 10857771003016

case of 6 ea

BIOMEDICAL LIFE SYSTEMS, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10857771003016
• NIH Device Record Key: ece369f0-28cc-4959-ab89-3a5dd8d8e7c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rebound
• Version Model Number: Rebound Health
• Catalog Number: KBTR6
• Company DUNS: 116956807
• Company Name: BIOMEDICAL LIFE SYSTEMS, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 7607275600
• Email: information@bmls.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10857771003016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102051

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Rebound]

• 00857771003101: Sport 1/bx
• 00857771003019: Rebound Health 1/bx
• 10857771003108: Rebound Sport 6/cs
• 10857771003016: case of 6 ea