GM-30 Accessory Kit

GUDID 04543660023492

This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device. OKAY® II Y-Connector Set with Extension Tube 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. (YOK0E) 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.

INFRAREDX, INC.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 04543660023492
• NIH Device Record Key: 237aa8cd-90b8-4933-8101-4890ae0cab01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GM-30 Accessory Kit
• Version Model Number: GLGMF-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: true
• 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

• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com
• Phone: 800-596-3104
• Email: customerservice@infraredx.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
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• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
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• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
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• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	04543660023492 [Primary]

FDA Product Code

• PTM: Syringe, Balloon Inflation, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-11
• Device Publish Date: 2022-02-03

On-Brand Devices [GM-30 Accessory Kit]

• 04543660023515: This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1)
• 04543660023508: This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1)
• 04543660023492: This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extensi
• 04543660023485: This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extensi