Merit® Kit
10 catalogue numbers from 00884450256411, listed by Merit Medical Systems, Inc., United States, under Catheter, Hemodialysis, Implanted. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
10catalogue numbers in this listing
3510(k) clearances naming this product code
4recalls 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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-20 |
| Record revised | 2021-10-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 4, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450256411 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450256398 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450256404 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450137420 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450137406 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450137413 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450137451 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450137444 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450137437 | Label Line 1-Custom Dialysis Kit | In distribution |
| 00884450256343 | Label Line 1-Custom Dialysis Kit | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151967 | 2016-04-04 |
| K141363 | 2014-06-18 |
| K090148 | 2009-04-13 |
Recalls
4 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-02-13 | Class I | Process control | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future | 47,153 |
| 2026-02-13 | Class I | Process control | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future | 131 |
| 2026-02-13 | Class I | Process control | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future | 21,591 |
| 2026-02-13 | Class I | Process control | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future | 35,591 |
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.