Catalog Number

-

Brand Name

ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM 24 HOURS, SIZE 16F

Version/Model Number

3240007

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

6dac3704-388f-43d8-80bd-792da22e5059

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Package DI Number

05030267108978

Quantity per Package

15

Contains DI Package

05030267097845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-