AccessGUDID - DEVICE: Commwell (07290012672026)

GUDID

Device Identifier (DI) Information

Brand Name: Commwell
Version or Model: PhysioGlove ET System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5-056-00
Company Name: COMMWELL RESEARCH & DEVELOPMENT LTD.

Primary DI Number: 07290012672026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532013976 *Terms of Use

Device Description: An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of 12-lead recording of the same heartbeat. It records data in electronic or printed form for Bluetooth transmission to a mobile device for later Wi-Fi or GSM transmission to a predefined web server for analysis by software or by a healthcare professional.

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?
62329	Multichannel electrocardiograph, noninterpretive	An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple electrode sets (leads) simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of multiple-lead recording of the same heartbeat. It records data in electronic or printed form for later analysis by software or a healthcare professional.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DPS	Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133703	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: 784d127f-c7ec-4923-ab6d-20bafdde4073
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 25, 2017