AccessGUDID - DEVICE: Relaxis (00852335007076)

GUDID

Device Identifier (DI) Information

Brand Name: Relaxis
Version or Model: 09-0021-02RN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Relaxis

Primary DI Number: 00852335007076
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 963372995 *Terms of Use

Device Description: Packaged, Relaxis Battery, Medium, Rental

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?
62210	Restless legs syndrome vibratory counterstimulation system	A mains electricity (AC-powered) device assembly, which may include rechargeable batteries, intended to reduce the symptoms of Restless Legs Syndrome (RLS) and improve sleep through vibratory counterstimulation. It includes a controller and a vibratory pad which is placed in contact with the patient’s legs whilst in bed to reduce the sensation of restless legs. It is intended for use in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVP	Vibratory Counter-Stimulation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: Medium

Device Record Status

Public Device Record Key: 378c1edd-855e-41b7-8ce0-5f306cbef2d8
Public Version Date: July 16, 2020
Public Version Number: 4
DI Record Publish Date: September 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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