DEVICE: N/A (00840682105217)
Device Identifier (DI) Information
N/A
2012196-001
In Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
2012196-001
In Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
No description.
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? |
---|---|---|---|---|
36869 | Computer network router |
A device designed to steer data between the client and the serving unit, e.g., between a bedside patient monitor and a central patient monitoring unit. It may be part of a patient monitoring system.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MWI | MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K021454 | 000 |
K033672 | 000 |
K040559 | 000 |
K051518 | 000 |
K071982 | 000 |
K103432 | 000 |
K142840 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
767a3bab-c0a9-427e-abca-fb2a2974555a
July 06, 2018
3
June 17, 2016
July 06, 2018
3
June 17, 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(800)558-5120
xx@xx.xx
xx@xx.xx