Pro-Tech P1336

GUDID 00606959010239

Pro-Tech Airflow Sensor Thermistor 1, Pediatric

Respironics, Inc.

Airway temperature monitoring system

• Primary Device ID: 00606959010239
• NIH Device Record Key: 55e74302-4cd1-4f13-a5b1-4a70fe883ec7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Tech
• Version Model Number: AIRFLOW SENSOR THERMISTOR
• Catalog Number: P1336
• Company DUNS: 080728314
• Company Name: Respironics, 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: true
• Serial Number: false
• 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(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959010239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960851

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: 2016-09-02

On-Brand Devices [Pro-Tech]

• 00606959011243: Pro-Tech Snore Microphone
• 00606959011236: Pro-Tech Sensor, Snore Embletta
• 00606959011229: Pro-Tech Snore Sensor
• 00606959010758: Pro-Tech Piezo 1 Sensor, Effort CT, Adult
• 00606959010635: Pro-Tech ezRIP Adult Kit, 249, 16"24"
• 00606959010307: Pro-Tech Airflow Sensor Thermistor, Neonatal 249
• 00606959010291: Pro-Tech Airflow Sensor Thermistor 1, Neonatal,
• 00606959010253: Pro-Tech Airflow Sensor Thermistory 1 Pediatric Embletta
• 00606959010246: Pro-Tech Airflow Sensor Thermistor Pediatrics, 249
• 00606959010239: Pro-Tech Airflow Sensor Thermistor 1, Pediatric
• 00606959010215: Pro-Tech Airflow Sensor Thermistor Pediatric 1 Alice 3
• 00606959010208: Pro-Tech Airflow Sensor, Thermistor, Oral, Alice PDx
• 00606959010178: Pro-Tech Airflow Sensor Thermistor
• 00606959010161: Pro-Tech Airflow Sensor Thermistor 1 Adult Embletta
• 00606959010154: Pro-Tech Airflow Sensor Thermistor
• 00606959010147: Pro-Tech Airflow Sensor Thermistor, Alice PDx, NasalOral, Adult
• 00606959010123: Pro-Tech Airflow Thermistor .10K, Adult,1.55mm
• 00606959010116: Pro-Tech Airflow Sensor Thermistor 1 Adult Cannula Style Alice 4
• 00606959010109: Pro-Tech Airflow Sensor 1, Adult, Cannula Style Alice 3
• 00606959010079: Pro-Tech Thermocouple Air Flow Sensor 1, Pediatric
• 00606959009998: Pro-Tech, Air Flow Sensor 2, Adult Cannula Style
• 00606959009981: Airflow Sensor 1, Channel, Adult, Cannula Style
• 00606959009974: Air Flow Sensor 1, Single Element, 6"
• 00606959009783: Pro-Tech Cannula Adapter Kit
• 00606959007239: Pro-Tech Air Flow Sensor 1, Pediatric Cannula Style
• 00606959006126: Pro-Tech Stardust PTAF sensor
• 00606959006096: Pro-Tech PTAF 2 Module Sensor Kit
• 00606959005105: Pro-Tech Double Port CPAP Titration Kit
• 00606959004795: Pro-Tech Airflow Sensor Thermistor, Oral, 249
• 00606959004788: Pro-Tech Airflow Thermistor, .10k Adult,
• 00606959004771: Pro-Tech Snore Microphone, 249
• 00606959040205: AF,CANNULA SAMPLE PACK. Cannula sample pack includes two of each of the following part numbers P
• 30606959037206: Pro-Tech Airflow Sensor Thermocouple, RoHS, Adult, Disposable
• 00606959037199: Pro-Tech Grass Airflow Sensor Thermocouple Adult, ONT-2
• 40606959033236: Filter 22mm .2micron PVC
• 30606959032362: PRO-FLOW MULTIPURPOSE NASAL CANNULA, 0.20x0.35, SINGLE
• 30606959032348: PRO-FLOW PLUS MULTIPURPOSE NASALORAL CANNULA ADULT SINGLE
• 30606959032331: PRO-FLOW PLUS MULTIPURPOSE ORAL CANNULA, PEDIATRIC, REGULAR, SINGLE
• 40606959032321: PRO-FLOW MULTIPURPOSE NASAL CANNULA, ADULT, SINGLE
• 30606959032317: PRO-FLOW MULTIPURPOSE NASAL CANNULA, PEDIATRIC SMALL, SINGLE
• 30606959032300: Pro-Flow Multipurpose Nasal Cannula, Pediatric, Single Pack
• 30606959032294: Pro-Flow Plus, A8.25" EMBLETTA
• 30606959032287: PRO-FLOW PLUS, NASAL ORAL , CANNULA ADULT 8.25" SINGLE
• 30606959032270: PRO-FLOW PLUS, NASALORAL, CANNULA ADULT 16", SINGLE
• 30606959032263: PRO-FLOW- PLUS NASALORAL CANNULA ADULT 1.1M SINGLE
• 40606959032253: PRO-FLOW PLUS NASALORAL CANNULA, PEDIATRICS, 7' SINGLE
• 30606959032249: PRO-FLOW Plus Nasal Oral Cannula Adult 7' Single
• 30606959032232: PRO-FLOW NASAL CANNULA, ADULT 1.1M Single
• 30606959032225: PRO-FLOW NASAL CANNULA, ADULT 8.25" SGL
• 30606959032218: PRO-FLOW NASAL CANNUAL, ADULT 16", SINGLE