Catalog Number

-

Brand Name

MEDI-CHOICE

Version/Model Number

TRAC1001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

K842166

Product Code

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

050a7ed9-eb1c-4aac-a406-23db674bcf77

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

August 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-