AccessGUDID - DEVICE: M12 System (00815187020754)

GUDID

Device Identifier (DI) Information

Brand Name: M12 System
Version or Model: 000-400-0129
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000-400-0129
Company Name: GLOBAL INSTRUMENTATION, LLC

Primary DI Number: 00815187020754
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 147035427 *Terms of Use

Device Description: SD Card (GI Label)

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?
35162	Electrocardiographic ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051730	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: c0933f61-8de3-4806-891a-3a12485d8d3e
Public Version Date: December 11, 2024
Public Version Number: 1
DI Record Publish Date: December 03, 2024