TeleRehab Rack Server

Basic Information

• Brand Name: TeleRehab Rack Server
• Primary DI: 00856298006305
• Version / Model: TeleRehab Rack Server
• Catalog Number: 100666
• 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: a7a06e30-6cd0-418a-b4e0-249de40c66fb

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856298006305	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050778	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity