GamCath HighFlow Dolphin Catheter
Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath HighFlow Catheter with an additional…
Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath HighFlow Catheter with an additional coating based on a block copolymer.
1manufacturer
10catalogue numbers in this listing
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 | Gambro Kathetertechnik Hechingen – Zweigniederlassung der Gambro Dialysatoren GmbH |
|---|---|
| FDA product code | MPB |
| Device type | Catheter, Hemodialysis, Non-Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| 510(k) | K100451 |
| Record published | 2015-10-07 |
| Record revised | 2023-07-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry. Keep away from sunlight.; Storage environment temperature up to 30 °C |
| Packaging | Case of 5 |
| Sizes | Length 150 to 250 mm; catheter gauge 11.5 to 13 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GAMCATH MS-GDHC-1115 A | Length 150 mm | In distribution |
| GAMCATH MS-GDHC-1125 A | Length 250 mm | In distribution |
| GAMCATH MS-GDHC-1325 A | STRAIGHT | In distribution |
| GAMCATH MS-GDHC-1120J A | Length 200 mm | In distribution |
| GAMCATH MS-GDHC-1115J A | Catheter Gauge 11.5 Fr | In distribution |
| GAMCATH MS-GDHC-1315J A | CURVED | In distribution |
| GAMCATH MS-GDHC-1120 A | Length 200 mm | In distribution |
| GAMCATH MS-GDHC-1320 A | Catheter Gauge 13 Fr | In distribution |
| GAMCATH MS-GDHC-1320J A | Length 200 mm | In distribution |
| GAMCATH MS-GDHC-1315 A | Catheter Gauge 13 Fr | In distribution |
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 |
| 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 |
Showing 12 of 59. All products under Catheter, Hemodialysis, Non-Implanted
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.