Catalog Number

-

Brand Name

AQUARIUS

Version/Model Number

103073001280AQ

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

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

ab5cad59-3b53-40d7-9091-69804180f30c

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

November 01, 2016

Package DI Number

27290000846570

Quantity per Package

2

Contains DI Package

07290000846576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box