Catalog Number

AEGCAP-BNS

Brand Name

Ameritus

Version/Model Number

AEGCAP-BNS

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,K110853

Product Code

FPD

Product Code Name

Tube, Feeding

Public Device Record Key

7b26269d-546c-4658-be3e-f8540ca5d6da

Public Version Date

September 11, 2019

Public Version Number

1

DI Record Publish Date

September 03, 2019

Package DI Number

30817522013248

Quantity per Package

10000

Contains DI Package

10817522013244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case