Catalog Number

-

Brand Name

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

Version/Model Number

3721002

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

f5e3d5c6-e18b-481c-9d9b-37c682602ddb

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

05030267143887

Quantity per Package

15

Contains DI Package

05030267143870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-