basixCOMPAK™
16 catalogue numbers from 00884450299401, listed by Merit Medical Systems, Inc., United States, under Syringe, Balloon Inflation. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
16catalogue numbers in this listing
6510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | MAV |
| Device type | Syringe, Balloon Inflation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-05-01 |
| Record revised | 2026-01-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 4, pack of 5 |
| Distribution end date | 2026-01-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450299401 | In distribution | |
| 00884450154946 | In distribution | |
| 00884450544655 | In distribution | |
| 00884450297353 | In distribution | |
| 00884450544679 | In distribution | |
| 00884450155004 | In distribution | |
| 00884450544686 | In distribution | |
| 00884450016756 | In distribution | |
| 00884450007990 | In distribution | |
| 00884450154991 | In distribution | |
| 00884450498569 | In distribution | |
| 00884450051405 | In distribution | |
| 00884450299364 | In distribution | |
| 00884450544624 | In distribution | |
| 00884450154977 | In distribution | |
| 00884450154984 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 18 |
| Everest™ | Medtronic, Inc. | 16 |
| QL Disposable Inflation Device | Atrion Medical Products, Inc. | 15 |
| basixTOUCH™ | Merit Medical Systems, Inc. | 12 |
| Fluent™ inflation device | Vascular Solutions LLC | 10 |
| Indeflator | Abbott Vascular | 6 |
| DeRoyal | Deroyal Industries, Inc. | 4 |
| QL Locking Syringe Device | Atrion Medical Products, Inc. | 4 |
| QL® Inflation Device | Atrion Medical Products, Inc. | 4 |
| Sphere™ Inflation Device | Atrion Medical Products, Inc. | 3 |
| Medex | ICU Medical, Inc | 3 |
| DiamondTOUCH™ | Merit Medical Systems, Inc. | 3 |
Showing 12 of 39. All products under Syringe, Balloon Inflation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153672 | 2016-01-20 |
| K130566 | 2013-06-19 |
| K040138 | 2004-02-13 |
| K993341 | 1999-10-25 |
| K943597 | 1995-02-10 |
| K913994 | 1992-02-04 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-08-25 | Class II | Labeling design | Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information. | 1,297 total units | 2016-12-01 |
| 2005-11-07 | Not classified | Other | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. | 35 units | 2006-03-14 |
| 2005-11-07 | Not classified | Other | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. | 26 units | 2006-03-14 |
| 2005-11-07 | Not classified | Other | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. | 38 units | 2006-03-14 |
| 2005-11-07 | Not classified | Other | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. | 24 units | 2006-03-14 |
| 2005-10-21 | Not classified | Other | Inflation device may not hold vacuum during angioplasty procedure. | 243 units | 2006-05-25 |
| 2005-10-21 | Not classified | Other | Inflation device may not hold vacuum during angioplasty procedure. | 62 units | 2006-05-25 |
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.