Model: v2.1830.2223.160
DI: 00850043189107
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3cc5658c-cbc7-4c24-b7ed-0dd497caf612
Distribution Status:
In Commercial Distribution
DUNS Number:
117717592
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850043189107
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41651
Name: Electrocardiographic long-term ambulatory recording analyser application software
Definition:
A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
FDA Product Codes
DQK
Computer, Diagnostic, Programmable
DPS
Electrocardiograph
Premarket Submissions
Submission Number:
K251218
Supplement Number:
000