T2100

Basic Information

• Brand Name: T2100
• Primary DI: 00840682106023
• Version / Model: Treadmill
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Labeler DUNS: 784985108
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-25
• Public Version: 4
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 86e3aaa6-7c0d-49d0-b640-2bc44308b873
• Distribution End Date: 2017-07-25

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
IOL	TREADMILL, POWERED	Physical Medicine	890.5380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36679	Cardiopulmonary stress exercise treadmill	An electrically-powered device designed to be used as a component of a stress test system that permits the evaluation of a patient's physiologic response to physical stress (e.g., workload testing of the cardiac and/or pulmonary disorders/function). It is designed for walking, jogging, or running on a moving belt that facilitates physical exercise while the patient remains on the spot (i.e., treadmill). It consists of an endless, continuous track (e.g., a shock-absorbing rubber belt rotating on rollers) that rotates at varying speeds and elevation, electric motors, and controls. It will typically incorporate front and side-mounted rails to allow the user to steady themselves.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682106023	GS1