MAK-NV™
MAK-NV™: 26 catalogue numbers listed by Merit Medical Systems, Inc., United States, under Needle, Catheter. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Jiangsu Yangtze River Medical Technology Corp. | Taizhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | GCB |
| Device type | Needle, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-06-12 |
| Record revised | 2025-03-28 (version 2) |
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 |
| Packaging | Pack of 10, pack of 15, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C | Needle Length (cm)-15 cm (6″) | In distribution |
| 00884450015636 | Introducer French Size (F)-6F | In distribution |
| 00884450088807 | Needle Length (cm)-15 cm (6″) | In distribution |
| 00884450015643 | Introducer French Size (F)-6F | In distribution |
| 00884450088883 | Needle Gauge (G)-21G | In distribution |
| 00884450088838 | Introducer Length (cm)-20 cm (8″) | In distribution |
| 00884450013588 | Introducer French Size (F)-6F | In distribution |
| 00884450088890 | Introducer Length (cm)-20 cm (8″) | In distribution |
| C | Needle Length (cm)-15 cm (6″) | In distribution |
| C | Introducer French Size (F)-6F | In distribution |
| 00884450013595 | Needle Gauge (G)-21G | In distribution |
| 00884450088876 | Introducer Length (cm)-20 cm (8″) | In distribution |
| 00884450088852 | Needle Length (cm)-15 cm (6″) | In distribution |
| C | Introducer French Size (F)-6F | In distribution |
| 00884450088814 | Introducer Length (cm)-20 cm (8″) | In distribution |
| 00884450088913 | Needle Length (cm)-20 cm (8″) | In distribution |
| 00884450013601 | Introducer Length (cm)-20 cm (8″) | In distribution |
| 00884450088821 | Introducer Length (cm)-20 cm (8″) | In distribution |
| 00884450088906 | Needle Gauge (G)-21G | In distribution |
| C | Introducer French Size (F)-6F | In distribution |
| 00884450088784 | Needle Length (cm)-15 cm (6″) | In distribution |
| 00884450088791 | Needle Length (cm)-15 cm (6″) | In distribution |
| 00884450088869 | Introducer French Size (F)-6F | In distribution |
| 00884450013571 | Needle Length (cm)-15 cm (6″) | In distribution |
| 00884450013564 | Needle Gauge (G)-21G | In distribution |
| 00884450088845 | Needle Length (cm)-15 cm (6″) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 17 |
| Ring-McLean | Cook Incorporated | 16 |
| Jet-Vac Procedure Trays | PFM Medical, Inc | 16 |
| Accel® | B. Braun Medical Inc. | 12 |
| Access Needle | Mermaid Medical A/S | 11 |
| Teleflex | Teleflex Medical LLC | 8 |
| Ring | Cook Incorporated | 7 |
| M-Drain Centesis Catheter | Mermaid Medical A/S | 6 |
| Accel™ | B. Braun Interventional Systems, Inc. | 5 |
| Pilling | Teleflex Medical LLC | 4 |
| Accel Centesis Catheter | PFM Medical, Inc | 4 |
| Skater™ Introducer System | Argon Medical Devices, Inc. | 3 |
Showing 12 of 30. All products under Needle, Catheter
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.