Revolution™
Catalogue number 00884450007945, listed by Merit Medical Systems, Inc., United States, under Device, Intravascular Catheter Securement. 33 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (13), Jiangsu (5), Shandong (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hubei Junyan Medical Science & Technology Co., Ltd. | Huanggang | Hubei | Contract manufacturer | 5 |
| Shandong Shinrise Medical Supplies Co., Ltd. | Zibo | Shandong | Contract manufacturer | 5 |
| Shandong Shinemed Technology Co., Ltd. | Zibo | Shandong | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
Showing 12 of 33. All 33 manufacturers in China registered for Device, Intravascular Catheter Securement
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | KMK |
| Device type | Device, Intravascular Catheter Securement |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5210 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-02-16 |
| Record revised | 2026-05-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450007945 | Catheter Range-6F – 24F | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Centurion | Centurion Medical Products Corporation | 190 |
| CathGrip | Argentum Medical, LLC | 120 |
| Statlock | Bard Access Systems, Inc. | 74 |
| Grip-Lok | Tidi Products, LLC | 44 |
| 3M™ Tegaderm™ | 3M Company | 33 |
| FlexGRIP | Bedal International NV | 30 |
| 3M™ Tegaderm™ | 3M Deutschland GmbH | 21 |
| LifeBubble | Novonate Inc | 15 |
| Clik-FIX | Starboard Medical, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 10 |
| Clik-Fix® | B. Braun Medical Inc. | 10 |
| Medline | Medline Industries, Inc. | 9 |
Showing 12 of 97. All products under Device, Intravascular Catheter Securement
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-02-15 | Not classified | Other | Sterility of some units may be compromised due to damaged packaging. | 195,001 units | 2011-11-09 |
| 2007-02-15 | Not classified | Other | Sterility of some units may be compromised due to damaged packaging. | 4223 units | 2011-11-09 |
| 2007-02-15 | Not classified | Other | Sterility of some units may be compromised due to damaged packaging. | 51,584 units | 2011-11-09 |
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.