RESPeRATE

GUDID 07290017402000

RESPeRATE lowers blood pressure by relaxing constricted blood vessels which cause high blood pressure. RESPeRATE does so by harnessing the therapeutic

2BREATHE TECHNOLOGIES LTD

Biofeedback system

• Primary Device ID: 07290017402000
• NIH Device Record Key: 2c50f1af-7a03-4903-8e05-b3f622add566
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESPeRATE
• Version Model Number: ULTRA
• Company DUNS: 600025387
• Company Name: 2BREATHE TECHNOLOGIES LTD
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017402000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020399

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-19

On-Brand Devices [RESPeRATE]

• 07290017402017: RESPeRATE lowers blood pressure by relaxing constricted blood vessels which cause high blood pre
• 07290017402000: RESPeRATE lowers blood pressure by relaxing constricted blood vessels which cause high blood pre