Relaxis

GUDID 00852335007076

Packaged, Relaxis Battery, Medium, Rental

Relaxis

Restless legs syndrome vibratory counterstimulation system

• Primary Device ID: 00852335007076
• NIH Device Record Key: 378c1edd-855e-41b7-8ce0-5f306cbef2d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relaxis
• Version Model Number: 09-0021-02RN
• Company DUNS: 963372995
• Company Name: Relaxis
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx
• Phone: (888) 475-7435
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852335007076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN110011

FDA Product Code

• OVP: Vibratory Counter-Stimulation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Relaxis]

• 00852335007090: Packaged, Relaxis AC, Medium
• 00852335007083: Replacement Power Supply, Relaxis
• 00852335007076: Packaged, Relaxis Battery, Medium, Rental
• 00852335007069: Packaged, Relaxis Battery, Medium, Refurbished
• 00852335007052: Packaged, Relaxis Battery, Medium
• 00852335007038: Packaged, Relaxis AC, Medium, Rental
• 00852335007021: Packaged, Relaxis AC, Medium, Refurbished