Statlock
StatlockTM Stabilization devices (PICC Plus, Pediatric, Teddy Bear Foam Pad, Sliding Post Retainer)
33manufacturers in China registered for this device type
74catalogue numbers in this listing
4recalls on this 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 | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | KMK |
| Device type | Device, Intravascular Catheter Securement |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5210 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-12-13 |
| Record revised | 2026-05-18 (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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 10, shelfpack of 50, shelfpack of 25, pack or inner pack of 25, pack or inner pack of 50, case of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DI0120 | In distribution | ||
| VCDC2 | In distribution | ||
| 10045560 | In distribution | ||
| S04020010 | 500 | In distribution | |
| VPPPSP | In distribution | ||
| IVK0120 | In distribution | ||
| CV0220CE | In distribution | ||
| VPPDFP | In distribution | ||
| D10120CE | In distribution | ||
| SEC2404321 | 500 | In distribution | |
| VNN2 | In distribution | ||
| IVK0100 | In distribution | ||
| VUPD1416 | In distribution | ||
| IVK0129 | In distribution | ||
| CV0321 | In distribution | ||
| VDS2 | In distribution | ||
| IV0520CE | In distribution | ||
| CV0223 | In distribution | ||
| VUPD1214 | In distribution | ||
| IV0631 | In distribution | ||
| CV0224 | In distribution | ||
| IVK0115 | In distribution | ||
| IB0200 | In distribution | ||
| VCDPC | In distribution | ||
| IVK0104 | In distribution | ||
| IV0220 | In distribution | ||
| NN0300 | In distribution | ||
| VCDP | In distribution | ||
| VMPDC | In distribution | ||
| VIFP4 | In distribution | ||
| IVK0175 | In distribution | ||
| IV0630 | In distribution | ||
| MP0120 | In distribution | ||
| VPPDFPCE | In distribution | ||
| IV0528 | In distribution | ||
| PIC0222 | In distribution | ||
| IV0634 | In distribution | ||
| D05000002A | 500 | In distribution | |
| IVK0105 | In distribution | ||
| IV0500 | In distribution | ||
| VPPBFP | In distribution | ||
| PIC0220 | In distribution | ||
| CV0226 | In distribution | ||
| IVK0132 | In distribution | ||
| CV0220 | In distribution | ||
| VCDPS | In distribution | ||
| IV0568 | In distribution | ||
| VEDC | In distribution | ||
| IVK0108 | In distribution | ||
| NN0202 | In distribution | ||
| NN0400 | In distribution | ||
| VUPD68 | In distribution | ||
| IV0636 | In distribution | ||
| VUPD1012 | In distribution | ||
| IV0570 | In distribution | ||
| IV0520 | In distribution | ||
| IV0632 | In distribution | ||
| IVK0114 | In distribution | ||
| VPPCSP | In distribution | ||
| VCDC | In distribution | ||
| IV0501 | In distribution | ||
| VPPBSP | In distribution | ||
| 0684000493 | In distribution | ||
| VADAC | In distribution | ||
| 5083 | 1,000 | In distribution | |
| VCDPP | In distribution | ||
| VFS | In distribution | ||
| VHD | In distribution | ||
| IV0569 | In distribution | ||
| NN0201 | In distribution | ||
| IV0579 | In distribution | ||
| NN0200 | In distribution | ||
| 0684000472 | In distribution | ||
| IV0577 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Centurion | Centurion Medical Products Corporation | 190 |
| CathGrip | Argentum Medical, LLC | 120 |
| 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 |
| Bedal | Bedal International NV | 9 |
Showing 12 of 97. All products under Device, Intravascular Catheter Securement
Recalls
4 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 |
|---|---|---|---|---|---|
| 2017-04-25 | Class II | Process control | StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. | 4,500 units | 2017-08-21 |
| 2016-12-09 | Class II | Process design | Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.). | 30,000 units total | 2017-05-26 |
| 2016-12-09 | Class II | Process design | Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.). | 14,500 units total | 2017-05-26 |
| 2013-06-10 | Class II | Packaging | BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk includ | 3,875 units. | 2014-05-21 |
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.