Mahurkar
Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Components,13.5 Fr/Ch (4.5 mm) x 13.5 cm
1manufacturer
48catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Mozarc Medical US LLC, United States |
|---|---|
| FDA product code | MPB |
| Device type | Catheter, Hemodialysis, Non-Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K030209 |
| Record published | 2015-08-31 |
| Record revised | 2025-12-30 (version 13) |
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 | Storage environment temperature 59 to 86 °F |
| Packaging | Pack_or_inner_pack of 5, case of 15, pack_or_inner_pack of 15 |
| Sizes | Length 13.5 to 24 cm; catheter gauge 13.5 Fr |
| Distribution end date | 2024-04-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888135197 | Length 19.5 cm | In distribution |
| 8888135168 | Length 16 cm | In distribution |
| 8888135247 | Catheter Gauge 13.5 Fr | In distribution |
| 8888135163 | Length 16 cm | In distribution |
| 8888135136 | Length 13.5 cm | In distribution |
| 8888135161 | Length 16 cm | In distribution |
| 8888135244 | Length 24 cm | In distribution |
| 8888135198 | Length 19.5 cm | In distribution |
| 8888135164 | Length 16 cm | In distribution |
| 8888135142 | Catheter Gauge 13.5 Fr | In distribution |
| 8888135168 | Catheter Gauge 13.5 Fr | In distribution |
| 8888135241 | Length 24 cm | In distribution |
| 8888135131 | Length 13.5 cm | In distribution |
| 8888135165 | Length 16 cm | In distribution |
| 8888135197 | Length 19.5 cm | In distribution |
| 8888135134 | Length 13.5 cm | In distribution |
| 8888135141 | Length 19.5 cm | In distribution |
| 8888135191 | Length 19.5 cm | In distribution |
| 8888135243 | Length 24 cm | In distribution |
| 8888135195 | Length 19.5 cm | In distribution |
| 8888135162 | Length 16 cm | In distribution |
| 8888135135 | Length 13.5 cm | In distribution |
| 8888135138 | Length 13.5 cm | In distribution |
| 8888135138 | Catheter Gauge 13.5 Fr | In distribution |
| 8888135166 | Length 16 cm | In distribution |
| 8888135140 | Length 16 cm | In distribution |
| 8888135167 | Length 13.5 cm | In distribution |
| 8888135242 | Length 24 cm | In distribution |
| 8888135248 | Catheter Gauge 13.5 Fr | In distribution |
| 8888135133 | Length 13.5 cm | In distribution |
| 8888135192 | Length 19.5 cm | In distribution |
| 8888135198 | Catheter Gauge 13.5 Fr | In distribution |
| 8888135193 | Length 19.5 cm | In distribution |
| 8888135132 | Length 13.5 cm | In distribution |
| 8888135196 | Length 19.5 cm | In distribution |
| 8888135140 | Catheter Gauge 13.5 Fr | In distribution |
| 8888135167 | Catheter Gauge 13.5 Fr | In distribution |
| 8888135247 | Length 24 cm | In distribution |
| 8888135142 | Length 24 cm | In distribution |
| 8888135141 | Length 19.5 cm | In distribution |
| 8888135194 | Length 19.5 cm | In distribution |
| 8888135141 | Length 19.5 cm | In distribution |
| 8888135248 | Length 24 cm | In distribution |
| 8888135246 | Catheter Gauge 13.5 Fr | Withdrawn |
| 8888135139 | Catheter Gauge 13.5 Fr | Withdrawn |
| 8888135139 | Length 13.5 cm | Withdrawn |
| 8888135245 | Catheter Gauge 13.5 Fr | Withdrawn |
| 8888135137 | Catheter Gauge 13.5 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 376 |
| Mahurkar Elite | Mozarc Medical US LLC | 119 |
| DUO-Flow® | Medical Components Inc | 106 |
| 400XL | Medical Components Inc | 95 |
| DUO-Split® | Medical Components Inc | 69 |
| Soft-Line® Duo-Flow® | Medical Components Inc | 58 |
| Disposable Hemodialysis Access Catheter Set | Guangdong Baihe Medical Technology Co., Ltd. | 38 |
| Disposable Hemodialysis Access Catheter Set Double Lumen14F*16cm(Straight) | Guangdong Baihe Medical Technology Co., Ltd. | 31 |
| Turbo-Flo HD | Cook Incorporated | 28 |
| Duoglide | Bard Access Systems, Inc. | 24 |
| Niagara catheter | Bard Access Systems, Inc. | 23 |
| Niagara Slim-Cath catheter | Bard Access Systems, Inc. | 21 |
Showing 12 of 59. All products under Catheter, Hemodialysis, Non-Implanted
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2022-12-07 | Class I | Process design | There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 359,730 (23,003 US; 336,727 OUS) | |
| Covidien | 510(k) number | 2003-12-02 | Not classified | Other | Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm | 45 units | 2012-05-15 |
| Covidien | 510(k) number | 2003-12-02 | Not classified | Other | Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm | 10 | 2012-05-15 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2026-04-29 | Class II | Under Investigation by firm | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. | 25627 |
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.