Home GUDID 00195278840202 MAC
Primary DI 00195278840202
Brand MAC
Company Ge Medical Systems Information Technologies, Inc.
Model 7
Catalog number 22270007-021
Device description MAC 7 15 Leads UPG KIT
Published 2026-10-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name DHX System, Test, Carcinoembryonic Antigen DPS Electrocardiograph DQK Computer, Diagnostic, Programmable DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DHX System, Test, Carcinoembryonic Antigen Immunology 2 DPS Electrocardiograph Cardiovascular 2 DQK Computer, Diagnostic, Programmable Cardiovascular 2 DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00195278840202 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00195278840202 00195278840202 195278840202 0195278840202
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 118935631 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06946725572139 APK APK Technology Co.,Ltd. DSA 2026-10-13 04250413400485 3-channel ECG Electrode SOMNOmedics AG DSA 2026-10-09 G662ME3311 Maguire Maguire Enterprises, Inc. DSA 2026-10-09 G662ME3381 Maguire Maguire Enterprises, Inc. DSA 2026-10-09 00840416607345 FOGG SYSTEM COMPANY, INC. Fogg System Company, Inc. DSA 2026-10-05 00840416607352 FOGG SYSTEM COMPANY, INC. Fogg System Company, Inc. DSA 2026-10-05 00840416607369 FOGG SYSTEM COMPANY, INC. Fogg System Company, Inc. DSA 2026-10-05 00840416607376 FOGG SYSTEM COMPANY, INC. Fogg System Company, Inc. DSA 2026-10-05 00840416607383 FOGG SYSTEM COMPANY, INC. Fogg System Company, Inc. DSA 2026-10-05 00840416607390 FOGG SYSTEM COMPANY, INC. Fogg System Company, Inc. DSA 2026-10-05 00198953009567 Carescape ONE GE Healthcare Finland Oy DQK 2026-10-04 00198953009567 Carescape ONE GE Healthcare Finland Oy DPS 2026-10-04 00810209880118 CORE 500 Digital Stethoscope - Lilac Chestpiece Eko Health, Inc. DPS 2026-10-01 00810209880163 CORE 500 Digital Stethoscope FIGS Earpiece - Espresso Eko Health, Inc. DPS 2026-10-01 00810209880170 CORE 500 Digital Stethoscope FIGS Earpiece - Ruby Red Eko Health, Inc. DPS 2026-10-01 00810209880187 CORE 500 Digital Stethoscope - Ember Chestpiece Eko Health, Inc. DPS 2026-10-01 G662ME590015H1 Maguire Maguire Enterprises, Inc. DSA 2026-09-24 05415067057952 EnSite™ ST. JUDE MEDICAL, INC. DQK 2026-09-21 05415067057969 EnSite™ ST. JUDE MEDICAL, INC. DQK 2026-09-21 00191506063214 OPAL HDx™ BOSTON SCIENTIFIC CORPORATION DQK 2026-09-20 00191506063214 OPAL HDx™ BOSTON SCIENTIFIC CORPORATION DSA 2026-09-20 00885403523512 HemoSphere Alta Becton, Dickinson And Company DQK 2026-09-18 00885403523536 HemoSphere Alta Becton, Dickinson And Company DQK 2026-09-18 00885403533764 Smart Pressure Controller Becton, Dickinson And Company DQK 2026-09-18 00885403533771 Smart Pressure Controller Accessory Kit Becton, Dickinson And Company DQK 2026-09-18 00199150062911 N/A MEDTRONIC, INC. DQK 2026-09-04 03700506301775 INTEGRAL PROCESS Cables & Leadwires NISSHA MEDICAL TECHNOLOGIES SAS DSA 2026-08-27 00198953213063 ComboLab Ge Medical Systems Information Technologies, Inc. DQK 2026-08-26 00198953213087 CardioLab Ge Medical Systems Information Technologies, Inc. DQK 2026-08-26 00198953213094 Mac-Lab Ge Medical Systems Information Technologies, Inc. DQK 2026-08-26