Mahurkar Elite
Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Safety Components,13.5 Fr/Ch (4.5 mm) x 24 cm
1manufacturer
119catalogue 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) | K120674 |
| Record published | 2016-04-04 |
| Record revised | 2025-12-19 (version 15) |
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: Keep away from sunlight.; Storage environment temperature 15 to 30 °C; Handling environment temperature 59 to 86 °F |
| Packaging | Pack_or_inner_pack of 5 |
| Sizes | Length 13 to 30 cm; catheter gauge 12 to 13.5 Fr |
| Distribution end date | 2024-03-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888211313 | Length 13 cm | In distribution |
| 8888222420 | Catheter Gauge 12 Fr | In distribution |
| 8888221216 | Length 16 cm | In distribution |
| 8888221416 | Length 16 cm | In distribution |
| 8888211230 | Length 30 cm | In distribution |
| 8888212416 | Length 16 cm | In distribution |
| 8888223416 | Catheter Gauge 12 Fr | In distribution |
| 8888211213 | Length 13 cm | In distribution |
| 8888223216 | Catheter Gauge 12 Fr | In distribution |
| 8888222113 | Catheter Gauge 12 Fr | In distribution |
| 8888222224 | Length 24 cm | In distribution |
| 8888221224 | Length 24 cm | In distribution |
| 8888211424 | Catheter Gauge 13.5 Fr | In distribution |
| 8888222413 | Catheter Gauge 12 Fr | In distribution |
| 8888222416 | Length 16 cm | In distribution |
| 8888212413 | Catheter Gauge 13.5 Fr | In distribution |
| 8888213313 | Catheter Gauge 13.5 Fr | In distribution |
| 8888223313 | Catheter Gauge 12 Fr | In distribution |
| 8888222324 | Catheter Gauge 12 Fr | In distribution |
| 8888212220 | Catheter Gauge 13.5 Fr | In distribution |
| 8888221113 | Length 13 cm | In distribution |
| 8888222116 | Catheter Gauge 12 Fr | In distribution |
| 8888222120 | Catheter Gauge 12 Fr | In distribution |
| 8888211120 | Length 20 cm | In distribution |
| 8888221420 | Length 20 cm | In distribution |
| 8888211220 | Length 20 cm | In distribution |
| 8888222424 | Catheter Gauge 12 Fr | In distribution |
| 8888213213 | Length 13 cm | In distribution |
| 8888211330 | Catheter Gauge 13.5 Fr | In distribution |
| 8888213416 | Length 16 cm | In distribution |
| 8888213420 | Length 20 cm | In distribution |
| 8888211320 | Catheter Gauge 13.5 Fr | In distribution |
| 8888212116 | Catheter Gauge 13.5 Fr | In distribution |
| 8888213220 | Length 20 cm | In distribution |
| 8888212320 | Catheter Gauge 13.5 Fr | In distribution |
| 8888213416 | Length 16 cm | In distribution |
| 8888221330 | Catheter Gauge 12 Fr | In distribution |
| 8888221130 | Catheter Gauge 12 Fr | In distribution |
| 8888211424 | Length 24 cm | In distribution |
| 8888212313 | Length 13 cm | In distribution |
| 8888213413 | Catheter Gauge 13.5 Fr | In distribution |
| 8888222213 | Catheter Gauge 12 Fr | In distribution |
| 8888213116 | Catheter Gauge 13.5 Fr | In distribution |
| 8888211124 | Catheter Gauge 13.5 Fr | In distribution |
| 8888212224 | Catheter Gauge 13.5 Fr | In distribution |
| 8888223316 | Length 16 cm | In distribution |
| 8888212420 | Length 20 cm | In distribution |
| 8888223116 | Catheter Gauge 12 Fr | In distribution |
| 8888222316 | Catheter Gauge 12 Fr | In distribution |
| 8888223413 | Length 13 cm | In distribution |
| 8888212216 | Catheter Gauge 13.5 Fr | In distribution |
| 8888212424 | Catheter Gauge 13.5 Fr | In distribution |
| 8888222216 | Length 16 cm | In distribution |
| 8888221430 | Catheter Gauge 12 Fr | In distribution |
| 8888222313 | Length 13 cm | In distribution |
| 8888221413 | Catheter Gauge 12 Fr | In distribution |
| 8888212113 | Catheter Gauge 13.5 Fr | In distribution |
| 8888213316 | Length 16 cm | In distribution |
| 8888221424 | Catheter Gauge 12 Fr | In distribution |
| 8888222420 | Length 20 cm | In distribution |
| 8888221420 | Length 20 cm | In distribution |
| 8888223220 | Length 20 cm | In distribution |
| 8888222413 | Catheter Gauge 12 Fr | In distribution |
| 8888221324 | Catheter Gauge 12 Fr | In distribution |
| 8888211224 | Catheter Gauge 13.5 Fr | In distribution |
| 8888211430 | Catheter Gauge 13.5 Fr | In distribution |
| 8888212316 | Length 16 cm | In distribution |
| 8888221316 | Catheter Gauge 12 Fr | In distribution |
| 8888223420 | Length 20 cm | In distribution |
| 8888212420 | Length 20 cm | In distribution |
| 8888211216 | Catheter Gauge 13.5 Fr | In distribution |
| 8888222220 | Catheter Gauge 12 Fr | In distribution |
| 8888213320 | Length 20 cm | In distribution |
| 8888211430 | Length 30 cm | In distribution |
| 8888221313 | Catheter Gauge 12 Fr | In distribution |
| 8888213413 | Length 13 cm | In distribution |
| 8888212324 | Length 24 cm | In distribution |
| 8888221120 | Catheter Gauge 12 Fr | In distribution |
| 8888213216 | Catheter Gauge 13.5 Fr | In distribution |
| 8888222416 | Catheter Gauge 12 Fr | In distribution |
| 8888211420 | Length 20 cm | In distribution |
| 8888212424 | Length 24 cm | In distribution |
| 8888221416 | Length 16 cm | In distribution |
| 8888211420 | Catheter Gauge 13.5 Fr | In distribution |
| 8888222320 | Catheter Gauge 12 Fr | In distribution |
| 8888223420 | Catheter Gauge 12 Fr | In distribution |
| 8888221213 | Length 13 cm | In distribution |
| 8888221116 | Length 16 cm | In distribution |
| 8888223213 | Catheter Gauge 12 Fr | In distribution |
| 8888211413 | Length 13 cm | In distribution |
| 8888221230 | Catheter Gauge 12 Fr | In distribution |
| 8888223416 | Catheter Gauge 12 Fr | In distribution |
| 8888211324 | Catheter Gauge 13.5 Fr | In distribution |
| 8888212413 | Length 13 cm | In distribution |
| 8888211316 | Catheter Gauge 13.5 Fr | In distribution |
| 8888212213 | Length 13 cm | In distribution |
| 8888211413 | Catheter Gauge 13.5 Fr | In distribution |
| 8888222424 | Catheter Gauge 12 Fr | In distribution |
| 8888221430 | Catheter Gauge 12 Fr | In distribution |
| 8888223320 | Catheter Gauge 12 Fr | In distribution |
| 8888221220 | Length 20 cm | In distribution |
| 8888213420 | Length 20 cm | In distribution |
| 8888221413 | Length 13 cm | In distribution |
| 8888211416 | Length 16 cm | In distribution |
| 8888221424 | Catheter Gauge 12 Fr | In distribution |
| 8888221124 | Catheter Gauge 12 Fr | In distribution |
| 8888223413 | Catheter Gauge 12 Fr | In distribution |
| 8888223113 | Catheter Gauge 12 Fr | In distribution |
| 8888212416 | Length 16 cm | In distribution |
| 8888211416 | Catheter Gauge 13.5 Fr | In distribution |
| 8888213113 | Catheter Gauge 13.5 Fr | In distribution |
| 8888221320 | Length 20 cm | In distribution |
| 8888213120 | Catheter Gauge 13.5 Fr | Withdrawn |
| 8888212120 | Catheter Gauge 13.5 Fr | Withdrawn |
| 8888212124 | Length 24 cm | Withdrawn |
| 8888222124 | Catheter Gauge 12 Fr | Withdrawn |
| 8888211113 | Catheter Gauge 13.5 Fr | Withdrawn |
| 8888211116 | Length 16 cm | Withdrawn |
| 8888223120 | Length 20 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 376 |
| 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 |
| Mahurkar | Mozarc Medical US LLC | 48 |
| 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
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mozarc Medical US LLC | 510(k) number | 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 | |
| Covidien | 510(k) number | 2017-10-14 | Class II | Process control | Medtronic is voluntarily recalling one lot of its MAHURKAR”* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKA | 2018-06-15 |
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.