Catalog Number

AS830P

Brand Name

AMSure® Suction Connecting Tube with Pre-Attached Yankauer

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

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

-

Product Code

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Public Device Record Key

587875ad-88b9-4069-9beb-5750e669b2de

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

40704411002650

Quantity per Package

50

Contains DI Package

10704411002659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case