Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

77505D

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"

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

4ee70652-fd23-4862-a7e2-1941452c526f

Public Version Date

December 29, 2021

Public Version Number

1

DI Record Publish Date

December 21, 2021

Package DI Number

20809160364175

Quantity per Package

20

Contains DI Package

10809160364178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-