Catalog Number

-

Brand Name

Posey Cufflators Endotracheal Tube Inflator and Manometer

Version/Model Number

8199

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

Product Code

BSK

Product Code Name

Cuff, Tracheal Tube, Inflatable

Public Device Record Key

c7e62a9d-facb-423a-819a-33185aa03e7c

Public Version Date

October 20, 2022

Public Version Number

5

DI Record Publish Date

October 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-