Catalog Number

SP19644

Brand Name

Manifold Kit

Version/Model Number

SP19644

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"

-

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

OJA

Product Code Name

Intravenous Extension Tubing Set

Public Device Record Key

0d768d88-83ec-4d68-812a-4ebf5204c8ad

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Package DI Number

20886333222920

Quantity per Package

5

Contains DI Package

00886333222926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box