Catalog Number

MSTC-022594

Brand Name

MedStream

Version/Model Number

MSTC-022594

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

NXA

Product Code Name

Tracheotomy Care Kit

Public Device Record Key

d6fab40c-bca6-4f65-a379-c6943b9f17ea

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

February 13, 2019

Package DI Number

10842472106890

Quantity per Package

30

Contains DI Package

00842472106893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-