AccessGUDID - DEVICE: Patient Monitor (06938368100046)

GUDID

Device Identifier (DI) Information

Brand Name: Patient Monitor
Version or Model: G3C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: General Meditech. Inc.

Primary DI Number: 06938368100046
Issuing Agency: GS1
Commercial Distribution End Date: August 22, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 545261786 *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):	No
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?
43239	Cardiac arrhythmia monitoring system	An assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.	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 [?]
K092970	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8eaf8a34-b837-4907-8bac-4078df630851
Public Version Date: August 28, 2024
Public Version Number: 4
DI Record Publish Date: December 19, 2016