Catalog Number

-

Brand Name

Medichoice

Version/Model Number

TRAC1006

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

73333183-e930-434b-ac02-871a41ccf5e4

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

August 20, 2016

Package DI Number

50885632127173

Quantity per Package

5

Contains DI Package

10885632127175

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-