AccessGUDID - DEVICE: TeleSense/Chroma2 Download Cable (00856298006152)

GUDID

Device Identifier (DI) Information

Brand Name: TeleSense/Chroma2 Download Cable
Version or Model: TeleSense/Chroma2 Download Cable
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101825
Company Name: SCOTTCARE CORPORATION, THE

Primary DI Number: 00856298006152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808204957 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142180	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d431b9a4-7c6d-496d-a0af-ace71365abe2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016