AccessGUDID - DEVICE: EKG Patch (Medium) (00860007764400)

GUDID

Device Identifier (DI) Information

Brand Name: EKG Patch (Medium)
Version or Model: Adult 2.0 Medium
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PA020AOM0213C
Company Name: Mg Medical Products LLC

Primary DI Number: 00860007764400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094834451 *Terms of Use

Device Description: Electrocardiograph Electrode Patch (Adult Medium)

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":	Yes
For Single-Use:	Yes
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?
62597	Ambulatory recorder conductive patch	An adhesive patch intended to fix a patient-worn recorder (e.g., electrocardiographic long-term ambulatory recorder) to skin electrodes during long-term electrophysiological recording/monitoring [e.g., electrocardiogram (ECG)], and to transmit the electrical signals from the electrodes to the recorder. It is an electrical conducting patch made of metal and synthetic polymer materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 10 and 27 Degrees Celsius
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep Away from Light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b187648c-7824-44c0-9c10-c8e06e7bb797
Public Version Date: November 02, 2021
Public Version Number: 1
DI Record Publish Date: October 25, 2021