Catalog Number

AS384

Brand Name

AMSure® Suction Catheter Kit

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

e87ef0f3-826f-40df-a710-bfc84da0bd1c

Public Version Date

July 13, 2018

Public Version Number

1

DI Record Publish Date

June 12, 2018

Package DI Number

40704411008645

Quantity per Package

50

Contains DI Package

10704411008644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case