Catalog Number

PT99999000147A

Brand Name

MedStream

Version/Model Number

PT99999000147A

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

OXQ

Product Code Name

Dressing Change Tray

Public Device Record Key

eaa9bbe5-266a-4eff-b6b2-266ea4be49e2

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

January 19, 2018

Package DI Number

10842472106371

Quantity per Package

100

Contains DI Package

00842472106374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-