TeleSense/Chroma2 Download Cable

Basic Information

• Brand Name: TeleSense/Chroma2 Download Cable
• Primary DI: 00856298006152
• Version / Model: TeleSense/Chroma2 Download Cable
• Catalog Number: 101825
• Company Name: SCOTTCARE CORPORATION, THE
• Labeler DUNS: 808204957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d431b9a4-7c6d-496d-a0af-ace71365abe2

Device Description

USB cable designed to connect with TeleSenseRCM, TeleSense-E, and Chroma2 devices to download device data.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60743	Medical device USB cable	An insulated metal wire(s) intended to be used to standardize the connection between an electronic medical device and a computer for communication and/or power supply.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856298006152	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142180	000