Catalog Number

-

Brand Name

VitaloJAK

Version/Model Number

7100

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110525,K110525

Product Code

DSH

Product Code Name

RECORDER, MAGNETIC TAPE, MEDICAL

Public Device Record Key

cf23014f-9d37-46f5-bb58-7335b6dcef85

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

May 14, 2018

Package DI Number

05099169710023

Quantity per Package

1

Contains DI Package

15099169710020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-