BreathCO

GUDID 05099169297500

BREATHCO MONITOR

VITALOGRAPH (IRELAND) LIMITED

Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser Carbon monoxide breath analyser

• Primary Device ID: 05099169297500
• NIH Device Record Key: b1039487-e5cf-46cc-ae53-c90023a97869
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BreathCO
• Version Model Number: 2900
• Company DUNS: 219683489
• Company Name: VITALOGRAPH (IRELAND) LIMITED
• 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: 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: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169297500 [Package]; Contains: 15099196297501; Package: [1 Units]; In Commercial Distribution
GS1	15099169297507 [Primary]
GS1	15099196297501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K892524

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-15

On-Brand Devices [BreathCO]

• 05099169297500: BREATHCO MONITOR
• 15099196297501: BREATHCO MONITOR