Dale Catheter Securement Device
Dale CVC, PICC and Arterial Sheath Catheter Securement Device Kit
33manufacturers in China registered for this device type
7catalogue numbers in this listing
2510(k) clearances naming 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 | Dale Medical Products, Inc., United States |
|---|---|
| FDA product code | KMK |
| Device type | Device, Intravascular Catheter Securement |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5210 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-10 |
| Record revised | 2026-05-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Cool dry place |
| Packaging | Box of 50, 50 of 50 |
| Distribution end date | 2023-07-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 851 | Withdrawn | |
| 854 | Withdrawn | |
| 852 | Withdrawn | |
| 849 | Withdrawn | |
| 850 | Withdrawn | |
| 848 | Withdrawn | |
| 853 | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K894586 | 1989-08-15 |
| K873311 | 1987-11-05 |
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.