AccessGUDID - DEVICE: TeleRehab Computer (00856298006275)

GUDID

Device Identifier (DI) Information

Brand Name: TeleRehab Computer
Version or Model: TeleRehab Computer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101819
Company Name: SCOTTCARE CORPORATION, THE

Primary DI Number: 00856298006275
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808204957 *Terms of Use

Device Description: Computer workstation used in conjunction with TeleRehab software.

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):	No
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?
38452	Desktop computer	A non-dedicated, electrically-powered computer designed to be stationary on a desk or other work platform. It typically includes a microprocessor [central processing unit (CPU)], a monitor, and a keyboard/mouse. When used with dedicated software the computer may function as a medical device.	Active	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 [?]
K050778	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: 4e2c528a-74d4-43dd-aa14-67064c2bbdbd
Public Version Date: August 20, 2020
Public Version Number: 5
DI Record Publish Date: September 19, 2016