ThermiSense 5700E-0

GUDID 00607411401237

ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.

SALTER LABS

Respiratory apnoea monitoring system Respiratory apnoea monitoring system Respiratory apnoea monitoring system

• Primary Device ID: 00607411401237
• NIH Device Record Key: ea69149a-b93f-48b7-951a-5bc0bd75e0d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermiSense
• Version Model Number: 5700E-0
• Catalog Number: 5700E-0
• Company DUNS: 022721133
• Company Name: SALTER LABS
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411401237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151874

FDA Product Code

• BZQ: Monitor, breathing frequency

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: 2016-09-24

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• 10607411000451: ThermiSense® Oral/Nasal Air Flow Pressure and Gas Sampling Cannula (Adult) with Thermistor Hold
• 10607411000437: ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 2' (0.61 m) t
• 00607411000416: ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.
• 00607411000300: ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.
• 00607411000256: ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' lon
• 00607411000249: ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor without Interface Box (5700B). Reusab
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• 00607411000201: ThermiSense® (Pediatric) Oral/Nasal Thermal Air Flow Sensor Alice®3 with Airflow Pressure Cann
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