AccessGUDID - DEVICE: N/A (00840682140935)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: B1X5-F2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2104800-001
Company Name: Ge Medical Systems Information Technologies, Inc.

Primary DI Number: 00840682140935
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118935631 *Terms of Use

Device Description: ASSY SECOND FRAME

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
36757	Patient monitoring system module rack	A device typically designed as a framework or specially constructed holder where module devices used with a patient monitoring system can be plugged in and connected to the parent device usually by one cable. This device is typically used to facilitate connection to the patient from the modules using standard length cables and leads when the parent device is situated away from the patient (out of reach), e.g., the parent device may be mounted to a wall support or a ceiling pendant arm (Utility supply system).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201941	000
K213490	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 Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9915dac-fd26-481e-9efd-55e004460e43
Public Version Date: April 16, 2025
Public Version Number: 5
DI Record Publish Date: November 16, 2020