Mac-Lab

Basic Information

• Brand Name: Mac-Lab
• Primary DI: 00840682145985
• Version / Model: A1
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Labeler DUNS: 784985108
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-11
• Public Version: 2
• Public Version Date: 2021-12-16
• Public Version Status: Update
• Public Device Record Key: a5e050e0-d528-4f60-a5b4-46f0e43a332b

Device Description

Computer Mac-Lab Acquisition v7.0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQK	Computer, diagnostic, programmable	Cardiovascular	870.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17898	Cardiac electrophysiology analysis system	An assembly of devices designed to perform several diagnostic tests and therapeutic treatments of the heart in patients with arrhythmic or conduction disorders. It typically consists of a computerized workstation including a monitor, a printer or graphic recorder, a data recorder (e.g., optical or magnetic disk), and plug-in modules for signal amplification and/or conditioning. Signals are taken from external electrodes on the chest as well as from intracardiac electrodes and from blood pressure transducers. Device uses include analysis of the atrioventricular conduction system, defibrillator function, and the induction/termination of ventricular tachycardia.	No	Active
37807	Cardiac catheterization monitoring system	An assembly of devices designed to continuously obtain, amplify, and record various signals generated during procedures usually performed in the cardiac catheterization laboratory. It typically consists of a computerized central workstation including a monitor and a graphic recorder, and a slave monitor including patient interface modules in the catheterization laboratory. The system is used for procedures such as left heart catheterization, right heart catheterization ventriculograms, coronary angiography, and pacemaker insertions; also used in procedures intended for the determination of most haemodynamic characteristics, evaluation of therapies, and planning of surgical approaches.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682145985	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K130626	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity