Catalog Number

MSTC-010613

Brand Name

MedStream

Version/Model Number

MSTC-010613

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

89d5461e-32fc-4bf7-96b4-50fe1ffa98cd

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

10842472102380

Quantity per Package

20

Contains DI Package

00842472102383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-