Veridian Healthcare - TENS unit with heat and conductive back wrap - VERIDIAN HEALTHCARE LLC

Duns Number:830437997

Device Description: TENS unit with heat and conductive back wrap

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More Product Details

Catalog Number

22-033BW

Brand Name

Veridian Healthcare

Version/Model Number

22-033BW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Device Record Status

Public Device Record Key

683b225e-4d73-445d-9a70-9243a8a29d83

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

March 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VERIDIAN HEALTHCARE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 127