basixCOMPAK™
58 catalogue numbers from 00884450535103, listed by Merit Medical Systems, Inc., United States, under Syringe, Balloon Inflation, Exempt. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
58catalogue numbers in this listing
6recalls on this code
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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | PTM |
| Device type | Syringe, Balloon Inflation, Exempt |
| 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 | 2021-04-28 |
| Record revised | 2025-05-13 (version 3) |
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, manufacturing date |
| Packaging | Pack of 10, pack of 5, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450535103 | In distribution | |
| 00884450498576 | In distribution | |
| 00884450638484 | In distribution | |
| 00884450535127 | In distribution | |
| 00884450544594 | In distribution | |
| 00884450498552 | In distribution | |
| T | In distribution | |
| 00884450638347 | In distribution | |
| 00884450544556 | In distribution | |
| 00884450637524 | In distribution | |
| 00884450544532 | In distribution | |
| 00884450638354 | In distribution | |
| 00884450638460 | In distribution | |
| 00884450544600 | In distribution | |
| 00884450535172 | In distribution | |
| 00884450544549 | In distribution | |
| 00884450638446 | In distribution | |
| 00884450498545 | In distribution | |
| 00884450299418 | In distribution | |
| 00884450498538 | In distribution | |
| 00884450638392 | In distribution | |
| 00884450544570 | In distribution | |
| 00884450544518 | In distribution | |
| 00884450498590 | In distribution | |
| 00884450535257 | In distribution | |
| 00884450638316 | In distribution | |
| 00884450535240 | In distribution | |
| A | In distribution | |
| 00884450535219 | In distribution | |
| 00884450535134 | In distribution | |
| 00884450638415 | In distribution | |
| T | In distribution | |
| 00884450498606 | In distribution | |
| 00884450638439 | In distribution | |
| 00884450638408 | In distribution | |
| 00884450498583 | In distribution | |
| T | In distribution | |
| 00884450638378 | In distribution | |
| 00884450544587 | In distribution | |
| 00884450544563 | In distribution | |
| 00884450544525 | In distribution | |
| 00884450544501 | In distribution | |
| 00884450638101 | In distribution | |
| 00884450638491 | In distribution | |
| 00884450544631 | In distribution | |
| 00884450638453 | In distribution | |
| 00884450638477 | In distribution | |
| 00884450638422 | In distribution | |
| 00884450638538 | In distribution | |
| 00884450544662 | In distribution | |
| 00884450645161 | In distribution | |
| 00884450638507 | In distribution | |
| 00884450638521 | In distribution | |
| 00884450544617 | In distribution | |
| Initial Release | In distribution | |
| 00884450638385 | In distribution | |
| 00884450638323 | In distribution | |
| 00884450617700 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| GM-30 Accessory Kit | Nipro Vascular Innovations Americas, 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
Recalls
6 of these are 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 |
|---|---|---|---|---|---|
| 2025-12-04 | Class II | Process control | Inflation device handle may detach from the syringe during procedure. | 4,163,123 units | |
| 2024-08-19 | Class II | Packaging process control | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. | 70 | |
| 2024-08-19 | Class II | Packaging process control | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. | 5 | |
| 2024-08-19 | Class II | Packaging process control | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. | 1952 | |
| 2024-08-19 | Class II | Packaging process control | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. | 16,439 | |
| 2021-06-10 | Class II | Device Design | Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. | 7,211 devices | 2024-05-15 |
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.