GM-30 Accessory Kit - This angioplasty convenience kit contains one(1) - INFRAREDX, INC.

Duns Number:124065421

Device Description: This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and o This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.The OKAY® II Y-Connector Set 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, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector 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.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.

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More Product Details

Catalog Number

-

Brand Name

GM-30 Accessory Kit

Version/Model Number

GLGMF-YOK0A

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

31d1e6f6-2c2c-4b73-a82d-e2a4559d16e5

Public Version Date

February 11, 2022

Public Version Number

1

DI Record Publish Date

February 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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