Catalog Number

-

Brand Name

NA

Version/Model Number

54-07-000

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K912723,K912723

Product Code

BSK

Product Code Name

Cuff, Tracheal Tube, Inflatable

Public Device Record Key

270231a0-a266-47c5-84c5-9f58a7ad7451

Public Version Date

September 30, 2021

Public Version Number

5

DI Record Publish Date

January 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-