Catalog Number

AS807

Brand Name

AMSure® 5-in-1 Connector

Version/Model Number

1

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

GCD

Product Code Name

Connector, Catheter

Public Device Record Key

383078a1-4185-4413-9a3d-4665784868c4

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

June 01, 2018

Package DI Number

40704411008065

Quantity per Package

100

Contains DI Package

10704411008064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case