13C-Spirulina GEBT

GUDID M763K0211

13C-Spirulina Gastric Emptying Breath Test (GEBT)

ADVANCED BREATH DIAGNOSTICS, LLC

Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD

• Primary Device ID: M763K0211
• NIH Device Record Key: 7d886a74-c9e5-4d15-8355-f072c7795ce6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 13C-Spirulina GEBT
• Version Model Number: K021
• Company DUNS: 055362540
• Company Name: ADVANCED BREATH DIAGNOSTICS, LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com
• Phone: +1 615 376 5464
• Email: cwilliams@cairndx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M763K0211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110015

FDA Product Code

• PGE: Gastric Emptying Breath Test

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-19
• Device Publish Date: 2015-10-13