DEVICE: N/A (00840682105217)

Device Identifier (DI) Information

N/A
2012196-001
In Commercial Distribution

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
00840682105217
GS1

1
784985108 *Terms of Use
No description.
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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
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FDA Product Code

[?]
Product Code Product Code Name
MWI MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K021454 000
K033672 000
K040559 000
K051518 000
K071982 000
K103432 000
K142840 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

767a3bab-c0a9-427e-abca-fb2a2974555a
July 06, 2018
3
June 17, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)558-5120
xx@xx.xx
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