AccessGUDID - DEVICE: MAC (00195278276087)

GUDID

Device Identifier (DI) Information

Brand Name: MAC
Version or Model: 5 LITE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8855003-001
Company Name: Ge Medical Systems Information Technologies, Inc.

Primary DI Number: 00195278276087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118935631 *Terms of Use

Device Description: MAC 5 Lite

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?
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
DXH	TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
DQK	Computer, diagnostic, programmable
DPS	Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221321	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: e67da0e4-e0ac-4cd5-b122-0f637b9ff060
Public Version Date: March 14, 2025
Public Version Number: 2
DI Record Publish Date: November 09, 2022