DEVICE: Sensosr (00606959007239)
Device Identifier (DI) Information
Sensosr
AIR FLOW SENSOR 1 CH.PEDIATRIC CANN.STYLE
In Commercial Distribution
P1223
Respironics, Inc.
AIR FLOW SENSOR 1 CH.PEDIATRIC CANN.STYLE
In Commercial Distribution
P1223
Respironics, Inc.
Air Flow Sensor 1, Pediatric Cannula Style
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35872 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZG | SPIROMETER, DIAGNOSTIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K913396 | 000 |
Sterilization
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
956eafb9-8919-4073-9198-c13a081a4d0e
January 27, 2021
4
September 06, 2016
January 27, 2021
4
September 06, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(724)744-2500
respironics.service@philips.com
respironics.service@philips.com