DEVICE: DreamStation (00606959022904)
Device Identifier (DI) Information
DreamStation
00
In Commercial Distribution
100710W
Respironics, Inc.
00
In Commercial Distribution
100710W
Respironics, Inc.
DreamStation WiFi Accessory, Canada
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Medical networking interface unit | An electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OUG | Medical device data system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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
3d3c3ff2-6723-4258-be56-08d2547baa6c
June 26, 2018
3
September 18, 2016
June 26, 2018
3
September 18, 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