Catalog Number

-

Brand Name

TRACHSEAL ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 72 HOUR

Version/Model Number

3721005

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

8584addb-242d-4ea4-b002-67436b7f55d1

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

05030267143900

Quantity per Package

15

Contains DI Package

05030267143894

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-