AccessGUDID - DEVICE: HD+12 (08056732652422)

GUDID

Device Identifier (DI) Information

Brand Name: HD+12
Version or Model: HD+12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 81018331
Company Name: CARDIOLINE SPA

Primary DI Number: 08056732652422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 339465174 *Terms of Use

Device Description: Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth or USB, sends the data to the host.

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?
16231	Electrocardiograph, professional, multichannel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency

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
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 54 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 54 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e13319b6-0f0b-47c7-bc9f-3e7da978f21a
Public Version Date: March 06, 2025
Public Version Number: 1
DI Record Publish Date: February 26, 2025