Catalog Number

AS829B

Brand Name

AMSure® Bubble Connecting Tube

Version/Model Number

1

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

-

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

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Public Device Record Key

5cb878f0-e365-468e-9ab0-c6045cbe944f

Public Version Date

June 08, 2021

Public Version Number

4

DI Record Publish Date

October 15, 2018

Package DI Number

50704411001025

Quantity per Package

5

Contains DI Package

10704411001027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master carton