CAIRE Diagnostics 900-0007

GUDID 00860008017925

Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for EU Instructions for Use, Fenom Pro, - P/N IFU-3264 AC Power Cord Cable, Europlug - PN 415-0011

Caire Diagnostics Inc.

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• Primary Device ID: 00860008017925
• NIH Device Record Key: 10c7a5ce-97c9-40ad-b937-a45de20ee938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAIRE Diagnostics
• Version Model Number: Fenom Pro, EU
• Catalog Number: 900-0007
• Company DUNS: 117548764
• Company Name: Caire Diagnostics 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008017925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182874

FDA Product Code

• MXA: System, Test, Breath Nitric Oxide

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: 2022-02-08
• Device Publish Date: 2022-01-31

On-Brand Devices [CAIRE Diagnostics]

• 00860008017956: Box of 50 Fenom Pro Mouthpieces, PN 810-0006 Sold in box of 50 only, individual mouthpieces are
• 00860008017949: Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/
• 00860008017932: Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured as a Demo Unit
• 00860008017925: Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for EU Instruc
• 00860008017918: Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for US Instruc
• 00860008017901: Package contains: External Power Supply, P/N 197-0001 Instructions for Use Reference, Fenom Pro