OKAY® II Y-Connector Set with Extension Tube

Primary DI
04543660022358
Brand
OKAY® II Y-Connector Set with Extension Tube
Company
Nipro Vascular Innovations Americas, Inc.
Model
YOK0E
Device description
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.
Published
2019-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14543660022355PackageGS15In Commercial Distribution
04543660022358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454366002235514543660022355
04543660022358045436600223584543660022358

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-596-3104customerservice@infraredx.com
800-596-3104customerservicenvia@nipromed.com

Regulatory Flags#

DUNS number
124065421
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857595006234Dualpro™ IVUS+NIRS Imaging Catheter Kit TVC-C195-42 TVC-C195-42 2018-07-11
00857595006494Dualpro™ IVUS+NIRS Imaging Catheter KitTVC-C195-42TVC-C195-422024-11-25
00857595006166Makoto Integrated Intravascular Imaging System™TVC-MC10iTVC-MC10i2022-11-11
00857595006180Infraredx Clarispro™ HD-IVUS Imaging Catheter KitTVC-E195-42 TVC-E195-42 2022-11-11
04543660023485GM-30 Accessory KitGLGMN-YOK0E2022-02-03
04543660023492GM-30 Accessory KitGLGMF-YOK0E2022-02-03
04543660023508GM-30 Accessory KitGLGMN-YOK0A2022-02-03
04543660023515GM-30 Accessory KitGLGMF-YOK0A2022-02-03
04543660022648GM-30 Inflation Device GM-30N GM-30N2021-03-05
04543660022655GM-30 Inflation Device GM-30NFGM-30NF2021-03-05
04543660022662GM-30 Inflation Device GM-30NLGM-30NL2021-03-05
04543660022334OKAY® II Y-Connector SetYOK0A2019-10-28
04543660022341OKAY® II Y-ConnectorYOK0B2019-10-28
00857595006005TVC Controller Sterile BarrierTVC-MC8-B1TVC-MC8-B12016-08-22
00857595006203TVC Insight™ TVC-C195-20TVC-C195-202016-09-15
00857595006210TVC Insight™ TVC-C195-22TVC-C195-222016-09-15
00857595006227TVC Insight XB™TVC-C195-32TVC-C195-322016-09-15
00857595006401TVC Imaging System™TVC-MC8TVC-MC8 2016-09-15
00857595006418TVC Imaging System™TVC-MC8TVC-MC82016-09-15
00857595006425TVC Imaging System™TVC-MC9TVC-MC92018-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489059199NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
10193489064520NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
10193489059151NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059175NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064506NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064537NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059144NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059168NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059182NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064483NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064490NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064513NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064544NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064551NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064568NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489058819NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058840NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058857NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058864NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058871NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058932NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058949NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058970NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
H965814001240NAMICANGIODYNAMICS, INC.DTL2020-11-03
07613327459210AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459180AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459197AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459203AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08