Pivot Breath Sensor

GUDID 00863571000318

CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.

Carbon monoxide breath analyser

• Primary Device ID: 00863571000318
• NIH Device Record Key: fd1c7aeb-41a0-41ee-b465-837eabf9d588
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pivot Breath Sensor
• Version Model Number: PFP-20300
• Company DUNS: 080137777
• Company Name: CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH 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: false
• 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: true

Customer Support Contacts

• Phone: 1-855-374-7727
• Email: support@pivot.co

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863571000318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171408

FDA Product Code

• CCJ: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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: 2019-12-17
• Device Publish Date: 2019-04-25

On-Brand Devices [Pivot Breath Sensor ]

• 08635710003014: PFP-20300
• 00863571000318: PFP-20300