AccessGUDID - DEVICE: H12+ (00817655022925)

GUDID

Device Identifier (DI) Information

Brand Name: H12+
Version or Model: H12PLUS-GAA-XXXXX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MORTARA INSTRUMENT, INC.

Primary DI Number: 00817655022925
Issuing Agency: GS1
Commercial Distribution End Date: March 08, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 062046149 *Terms of Use

Device Description: Holter Recorder

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?
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
MWJ	Electrocardiograph,Ambulatory(Without Analysis)

FDA Premarket Submission

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

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 Humidity: less than 95 Percent (%) Relative Humidity
Storage Environment Temperature: less than 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eee2f79d-80ed-44f5-a8dd-624a12352b0e
Public Version Date: March 09, 2023
Public Version Number: 5
DI Record Publish Date: January 04, 2018