Catalog Number

-

Brand Name

Vitalcontrol

Version/Model Number

SHK22 (Red)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

5e54b30c-d683-4c8f-a913-3b1551813a6b

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

October 31, 2021

Package DI Number

10850031772011

Quantity per Package

6

Contains DI Package

00850031772014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack