Catalog Number

AS3651

Brand Name

AMSure® Suction Catheter

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

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

1ca37417-eb1a-4d47-8ff8-fad2b254b18e

Public Version Date

October 26, 2020

Public Version Number

1

DI Record Publish Date

October 16, 2020

Package DI Number

40704411013137

Quantity per Package

50

Contains DI Package

10704411013136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case