ThermiSense 5761-7

GUDID 20607411300985

ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 7' (2.1 m) tube with male/female adaptor without filter

SALTER LABS

Respiratory apnoea monitoring system

• Primary Device ID: 20607411300985
• NIH Device Record Key: fe2d42b1-78c1-4d92-8144-26b3020b4221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermiSense
• Version Model Number: 5761-7
• Catalog Number: 5761-7
• 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: false
• Device Combination Product: false
• Single Use: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411300981 [Primary]
GS1	10607411300988 [Package]; Contains: 00607411300981; Package: [10 Units]; In Commercial Distribution
GS1	20607411300985 [Package]; Contains: 10607411300988; Package: [25 Units]; In Commercial Distribution

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

On-Brand Devices [ThermiSense]

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• 00607411401237: ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.
• 10607411301596: ThermiSense® Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder 2' (0.6 m) tube wit
• 00607411301506: ThermiSense® Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' long Malleabl
• 00607411301490: ThermiSense® Oral/Nasal Thermal Air Flow Sensor Alice®4 with Airflow Pressure Cannulas, Nasal
• 00607411301483: ThermiSense® Oral/Nasal Thermal Air Flow Sensor Alice®3 with Airflow Pressure Cannulas, Nasal
• 00607411301339: ThermiSense® Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/
• 20607411301241: ThermiSense® Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder 7' (2.1 m) tube wit
• 20607411301234: ThermiSense® Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder 7' (2.1 m) tube wit
• 00607411301001: ThermiSense® Interface Box For Use with ThermiSense® Oral/Nasal Thermal Air Flow Sensor No. 57
• 00607411300998: ThermiSense® Oral/Nasal Thermal Air Flow Sensor without Interface Box (5700B).
• 20607411300985: ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 7' (2.1 m) tu
• 10607411300971: ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 7' (2.1 m) tu
• 20607411201121: ThermiSense® Oral/Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor
• 00607411099540: ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' lon
• 00607411005725: ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with the Sandman® SD20 PSG System. Reu
• 10607411005593: ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Adult) with Thermistor Holder wi
• 00607411000492: ThermiSense® Oral/Nasal Thermal Air Flow Sensor (Pediatric) for use with a PSG System. Reusable
• 00607411000485: ThermiSense® Oral/Nasal Thermal Air Flow Sensor (Pediatric) for use with a PSG System. Reusable
• 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
• 00607411000232: ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' lon
• 00607411000201: ThermiSense® (Pediatric) Oral/Nasal Thermal Air Flow Sensor Alice®3 with Airflow Pressure Cann
• 00607411000195: ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal
• 10607411000185: ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor Holde
• 20607411000175: ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor Holde
• 00607411000164: ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.