Catalog Number

1141001

Brand Name

ADD-Vantage

Version/Model Number

1141001

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

K133602,K133602

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

a53690bf-18b8-4d95-bfa8-cd727e2eabf4

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

30887787001670

Quantity per Package

25

Contains DI Package

10887787001676

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case