DEVICE: VitalSense (00606959033337)
Device Identifier (DI) Information
VitalSense
VITALSENSE
In Commercial Distribution
500-0200-00
Respironics, Inc.
VITALSENSE
In Commercial Distribution
500-0200-00
Respironics, Inc.
Finished Good, VitalSense, Temperature Dermal Patch
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
55824 | Temperature telemetric monitoring system transmitter |
A body-worn, battery-powered component of a temperature telemetric monitoring system designed to continuously measure and wirelessly transmit core and/or skin temperature signals to the system's receiver. It typically consists of a portable radio transmitter to which are attached skin, tympanic, rectal, oesophageal, and/or ingestible temperature sensors. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FLL | Thermometer, electronic, clinical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K033534 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e7caad68-4230-4fb8-acfc-64e63193d57d
July 06, 2018
3
January 09, 2017
July 06, 2018
3
January 09, 2017
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