OKAY® II Y-Connector Set with Extension Tube
GUDID 04543660022358
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.
INFRAREDX, INC.
Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve| Primary Device ID | 04543660022358 |
| NIH Device Record Key | aeca7a44-aac4-48b8-8251-a622e22425d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OKAY® II Y-Connector Set with Extension Tube |
| Version Model Number | YOK0E |
| Company DUNS | 124065421 |
| Company Name | INFRAREDX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04543660022358 [Primary] |
| GS1 | 14543660022355 [Package] Package: Box [5 Units] In Commercial Distribution |
FDA Product Code
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2019-10-28 |
Devices Manufactured by INFRAREDX, INC.
| 00857595006166 - Makoto Integrated Intravascular Imaging System™ | 2022-11-21 The Makoto Integrated Intravascular Imaging System™ (TVC-MC10i) is a dual-modality intravascular imaging system that enables s |
| 00857595006180 - Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit | 2022-11-21 The Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit (TVC-E195-42) is a single use, disposable coronary and peripheral imagin |
| 04543660023485 - GM-30 Accessory Kit | 2022-02-11 This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch |
| 04543660023492 - GM-30 Accessory Kit | 2022-02-11 This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch |
| 04543660023508 - GM-30 Accessory Kit | 2022-02-11 This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Infla |
| 04543660023515 - GM-30 Accessory Kit | 2022-02-11 This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Infla |
| 04543660022648 - GM-30 Inflation Device | 2021-03-15 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 3 position stopcock for angioplasty ballo |
| 04543660022655 - GM-30 Inflation Device | 2021-03-15 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual an |
Trademark Results [OKAY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OKAY 98519484 not registered Live/Pending |
CESAM, LLC 2024-04-25 |
 OKAY 90899992 not registered Live/Pending |
Xtreme Tools International, Inc. 2021-08-24 |
 OKAY 90277356 not registered Live/Pending |
XIA, Chun Xian 2020-10-26 |
 OKAY 90221407 not registered Live/Pending |
EGO & ID, LLC 2020-09-29 |
 OKAY 85501305 not registered Dead/Abandoned |
Sutter Home Winery, Inc. 2011-12-21 |
 OKAY 85490612 4183066 Live/Registered |
OKAY INDUSTRIES, INC. 2011-12-08 |
 OKAY 85490592 4183062 Live/Registered |
OKAY INDUSTRIES, INC. 2011-12-08 |
 OKAY 85448955 4160631 Live/Registered |
Xtreme Tools, International 2011-10-17 |
 OKAY 85200313 not registered Dead/Abandoned |
Xtreme Tools International, Inc. 2010-12-17 |
 OKAY 79251388 5929349 Live/Registered |
Protectoria A.S. 2018-07-13 |
 OKAY 79231976 5567904 Live/Registered |
GOODMAN CO., LTD. 2018-03-07 |
 OKAY 79123533 not registered Dead/Abandoned |
Patricia Bech 2012-09-06 |
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