Catalog Number

-

Brand Name

Ambu A/S

Version/Model Number

321000702

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"

Yes

For Single-Use

Yes

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

4543e744-1df2-4c0e-9357-63e50391721d

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

March 26, 2018

Package DI Number

14250105628088

Quantity per Package

10

Contains DI Package

04250105628081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-