Catalog Number

193400

Brand Name

Manifold Kit #1

Version/Model Number

193400

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

949e7ef2-aaa7-4a01-8bcb-3b719c5b50ab

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

20886333207590

Quantity per Package

10

Contains DI Package

00886333207596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box