Catalog Number

E-1004

Brand Name

AMSure® SPIKE SET with SAFETY CONNECTOR

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 03, 2017

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

060a8d22-c662-4f51-8404-5dbcddc1ad2e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

40704411005378

Quantity per Package

30

Contains DI Package

10704411005377

Package Discontinue Date

July 03, 2017

Package Status

Not in Commercial Distribution

Package Type

Case