AccuRelief - AccuRelief Universal Supply KIT - Carex Health Brands

Duns Number:082522269

Device Description: AccuRelief Universal Supply KIT

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More Product Details

Catalog Number

-

Brand Name

AccuRelief

Version/Model Number

ACRL-0001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

a387c6de-f8f7-4187-8259-324764bf6552

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 05, 2016

Additional Identifiers

Package DI Number

30023601200014

Quantity per Package

6

Contains DI Package

00023601200013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK

"CAREX HEALTH BRANDS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 34