Turbo-Flo HD
Cook Turbo-Flo HD Hemodialysis Catheter Tray Double Lumen Polyurethane Catheter
1manufacturer
28catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | MPB |
| Device type | Catheter, Hemodialysis, Non-Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-24 |
| Record revised | 2022-02-03 (version 5) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2022-02-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G35095 | In distribution | |
| G35092 | In distribution | |
| G35093 | In distribution | |
| G35088 | In distribution | |
| G35087 | In distribution | |
| G35089 | In distribution | |
| G35086 | In distribution | |
| G35096 | In distribution | |
| G35094 | In distribution | |
| G35091 | In distribution | |
| G35090 | In distribution | |
| G35097 | In distribution | |
| G35102 | Withdrawn | |
| G35109 | Withdrawn | |
| G35107 | Withdrawn | |
| G35082 | Withdrawn | |
| G35101 | Withdrawn | |
| G35106 | Withdrawn | |
| G35099 | Withdrawn | |
| G44842 | Withdrawn | |
| G35084 | Withdrawn | |
| G35103 | Withdrawn | |
| G35083 | Withdrawn | |
| G35098 | Withdrawn | |
| G35105 | Withdrawn | |
| G35104 | Withdrawn | |
| G35108 | Withdrawn | |
| G35100 | Withdrawn |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 |
| 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161504 | 2017-01-06 |
| K122091 | 2013-07-29 |
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.