AccessGUDID - DEVICE: TeleRehab Rack Server (00856298006305)

GUDID

Device Identifier (DI) Information

Brand Name: TeleRehab Rack Server
Version or Model: TeleRehab Rack Server
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100666
Company Name: SCOTTCARE CORPORATION, THE

Primary DI Number: 00856298006305
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808204957 *Terms of Use

Device Description: No description.

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?
36870	Network server	A device designed to provide electronic data services within a computerized network (e.g., file services like collecting and storing data). It may be a part of a patient monitoring, nurse call, or home alert system.	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
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7a06e30-6cd0-418a-b4e0-249de40c66fb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016