Catalog Number

AS360C

Brand Name

AMSure® Coiled 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

b3a3a515-2cd8-4e3e-a9c5-79ba761fa2f6

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 05, 2018

Package DI Number

50704411010034

Quantity per Package

20

Contains DI Package

40704411010037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master carton