Catalog Number

-

Brand Name

MAI

Version/Model Number

81605

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)

-

Over the Counter (OTC)

Yes

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

9e485e8e-542f-4ca3-832f-17e269259fd1

Public Version Date

November 12, 2020

Public Version Number

1

DI Record Publish Date

November 04, 2020

Package DI Number

20809160295134

Quantity per Package

20

Contains DI Package

10809160295137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-