Tandem-Cath
Chronic Dual Catheter System,23 cm Arterial Cuff / 26 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm)
2manufacturers in China registered for this device type
4catalogue numbers in this listing
5recalls on this code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Mozarc Medical US LLC, United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K041006 |
| Record published | 2014-09-22 |
| Record revised | 2025-04-29 (version 8) |
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 |
| Storage | Special storage condition: ;AVOID DIRECT SUNLIGHT |
| Sizes | Catheter gauge 10 Fr |
| Distribution end date | 2020-10-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888219226 | Catheter Gauge 10 Fr | In distribution |
| 8888228316 | Catheter Gauge 10 Fr | In distribution |
| 8888223266 | Length,23 cm Arterial Cuff,N/A;Length,26 cm Venous Cuff,N/A; | Withdrawn |
| 8888200006 | Catheter Gauge 10 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 406 |
| Split Cath® III | Medical Components Inc | 277 |
| Palindrome | Mozarc Medical US LLC | 139 |
| Titan HD | Medical Components Inc | 75 |
| ProGuide™ | Merit Medical Systems, Inc. | 72 |
| Hemo-Flow® | Medical Components Inc | 65 |
| DuraMax® | Merit Medical Systems, Inc. | 55 |
| CentrosFLO® | Merit Medical Systems, Inc. | 51 |
| BioFlo DuraMax® | Merit Medical Systems, Inc. | 51 |
| BioFlo | Navilyst Medical, Inc. | 45 |
| DuraFlow | AngioDynamics, Inc. | 37 |
| Mahurkar | Mozarc Medical US LLC | 37 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
Recalls
5 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 |
|---|---|---|---|---|
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
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.