AccessGUDID - DEVICE: Pro-Tech (00606959010116)

GUDID

Device Identifier (DI) Information

Brand Name: Pro-Tech
Version or Model: AIRFLOW SENSOR THERMISTOR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1286
Company Name: Respironics, Inc.

Primary DI Number: 00606959010116
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: Pro-Tech Airflow Sensor Thermistor 1 Adult Cannula Style Alice 4

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Airway temperature monitoring system	An assembly of devices typically used bedside to continuously measure the temperature at a specific point along a ventilation airway (e.g., inspiratory limb, Y-piece). It typically includes a temperature sensor, a transducer, a cable, and an electronic unit with a display and alarms (audible and/or visual). The system provides real-time information on the temperature of the gases supplied to patients under assisted ventilation, particularly when a heated humidifier is incorporated into the inspiratory line of a patient's breathing circuit.

GMDN Preferred Term Name

GMDN Definition

Airway temperature monitoring system

An assembly of devices typically used bedside to continuously measure the temperature at a specific point along a ventilation airway (e.g., inspiratory limb, Y-piece). It typically includes a temperature sensor, a transducer, a cable, and an electronic unit with a display and alarms (audible and/or visual). The system provides real-time information on the temperature of the gases supplied to patients under assisted ventilation, particularly when a heated humidifier is incorporated into the inspiratory line of a patient's breathing circuit.

FDA Product Code

[?]

Product Code	Product Code Name
BZQ	Monitor, breathing frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960851	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e20d414-858e-4aac-9530-455b80c31600
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 02, 2016