SmartMonitor 2 w/o Modem 4002

GUDID B0364002

SmartMonitor 2 w/o Modem

CIRCADIANCE, LLC

Infant apnoea monitor

• Primary Device ID: B0364002
• NIH Device Record Key: 77b003cc-9291-429a-9051-d37fdd1d9d59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartMonitor 2 w/o Modem
• Version Model Number: 4002
• Catalog Number: 4002
• Company DUNS: 012721295
• Company Name: CIRCADIANCE, 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-825-9640
• Email: info@circadiance.com
• Phone: 1-888-825-9640
• Email: info@circadiance.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Battery Charge Temperature: 10ºC to 35ºC
• Handling Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Battery Charge Temperature: 10ºC to 35ºC

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0364002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011597

FDA Product Code

• FLS: Monitor, Apnea, Facility Use

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: 2015-12-02

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