Catalog Number

-

Brand Name

Therapy Supply

Version/Model Number

76512B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 2020

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

PEZ

Product Code Name

Central venous catheter dressing change kit

Public Device Record Key

5760780f-975f-47f4-82e0-b1302c081c36

Public Version Date

October 06, 2020

Public Version Number

5

DI Record Publish Date

April 24, 2017

Package DI Number

20809160145583

Quantity per Package

30

Contains DI Package

10809160145586

Package Discontinue Date

January 16, 2020

Package Status

Not in Commercial Distribution

Package Type

-