Catalog Number

E-1203

Brand Name

AMSure® ENTERAL FEEDING BAG with ATTACHED GRAVITY SET

Version/Model Number

2

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

3a5845b2-371f-43cb-a05c-09f7338578ee

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 03, 2017

Package DI Number

40704411006474

Quantity per Package

30

Contains DI Package

10704411006473

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case