Catalog Number

AEG10-KMS

Brand Name

Ameritus

Version/Model Number

AEG10-KMS

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

K110853,K110853,K110853

Product Code

FPD

Product Code Name

Tube, Feeding

Public Device Record Key

01e6a059-0a48-40d7-b27b-7754a27314f0

Public Version Date

October 29, 2021

Public Version Number

7

DI Record Publish Date

August 03, 2016

Package DI Number

30817522010001

Quantity per Package

1200

Contains DI Package

10817522010007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case