AccessGUDID - DEVICE: N/A (00840682105408)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Unity Network ID
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Primary DI Number: 00840682105408
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784985108 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d01d595-55ea-4b5b-93ea-1525e3596220
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 17, 2016