Catalog Number

-

Brand Name

Aligned Medical Solutions

Version/Model Number

MPT82379

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

-

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

6563b24d-6a76-4eb0-8580-dcd0c8fed044

Public Version Date

May 06, 2022

Public Version Number

1

DI Record Publish Date

April 28, 2022

Package DI Number

20809160370206

Quantity per Package

20

Contains DI Package

10809160370209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-