GM-30 Accessory Kit
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…
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.
Who Else Makes It
Concentrated in Jiangsu (7), Guangdong (4), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Brun Medical Co., Ltd. | Zhuzhou | Hunan | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Syringe, Balloon Inflation, Exempt
Record
| Listed by | Nipro Vascular Innovations Americas, Inc., United States |
|---|---|
| FDA product code | PTM |
| Device type | Syringe, Balloon Inflation, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-02-03 |
| Record revised | 2026-04-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry; Special storage condition: Do not use if package is damaged |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GLGMF-YOK0E | In distribution | |
| GLGMN-YOK0A | In distribution | |
| GLGMN-YOK0E | In distribution | |
| GLGMF-YOK0A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| basixCOMPAK™ | Merit Medical Systems, Inc. | 58 |
| basixTOUCH™ | Merit Medical Systems, Inc. | 21 |
| Angioway | Lepu Medical Technology (Beijing) Co., Ltd. | 14 |
| Balloon inflation device | Tianck Medical Co., Ltd. | 9 |
| basixALPHA™ | Merit Medical Systems, Inc. | 8 |
| Genoss Inflator B30 | Genoss Co., Ltd. | 5 |
| basixTau™ | Merit Medical Systems, Inc. | 5 |
| Genoss Inflator B40 | Genoss Co., Ltd. | 5 |
| Namic | Medline Industries, Inc. | 4 |
| BlueFIRE™ | Merit Medical Systems, Inc. | 4 |
| basixSKY™ | Merit Medical Systems, Inc. | 4 |
| GM-30 Inflation Device | Nipro Vascular Innovations Americas, Inc. | 3 |
Showing 12 of 25. All products under Syringe, Balloon Inflation, Exempt
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.