OKAY® II Y-Connector Set with Extension Tube - OKAY II reduces blood loss during procedures - INFRAREDX, INC.

Duns Number:124065421

Device Description: OKAY II reduces blood loss during procedures through the use of a hemostatic valve not fea OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.

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More Product Details

Catalog Number

-

Brand Name

OKAY® II Y-Connector Set with Extension Tube

Version/Model Number

YOK0E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DTL

Product Code Name

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

aeca7a44-aac4-48b8-8251-a622e22425d3

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

October 28, 2019

Additional Identifiers

Package DI Number

14543660022355

Quantity per Package

5

Contains DI Package

04543660022358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"INFRAREDX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13