Catalog Number

-

Brand Name

Puritan Bennett

Version/Model Number

180-03

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

-

Product Code

BSK

Product Code Name

Cuff, tracheal tube, inflatable

Public Device Record Key

f1ad6c58-e04b-4ed7-b1fb-58444b68cd37

Public Version Date

December 02, 2021

Public Version Number

2

DI Record Publish Date

June 18, 2021

Package DI Number

20884521782492

Quantity per Package

18

Contains DI Package

10884521782495

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE