Nipro SafeTouch Tulip Safety Fistula Needle
SafeTouch Tulip Safety AVF (15Gx1-1/4") 12" tube, fixed hub (twin pack)
1manufacturer
19catalogue numbers in this listing
1510(k) clearance
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 | Nipro Medical Corporation, United States |
|---|---|
| FDA product code | MPB |
| Device type | Catheter, Hemodialysis, Non-Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Complaint-file establishment, Exporter |
| Record published | 2023-09-15 |
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 |
| Packaging | Case of 6, box of 50, case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FT+172530BC | In distribution | |
| FT+152530TP | In distribution | |
| FT+142530BC | In distribution | |
| FT+162530BCR | In distribution | |
| FT+142530TP | In distribution | |
| FT+162540BC | In distribution | |
| FT+152530BCR | In distribution | |
| FT+172530TP | In distribution | |
| FT+163230BC | In distribution | |
| FT+153230TP | In distribution | |
| FT+162530TP | In distribution | |
| FT+173230TP | In distribution | |
| FT+162530BC | In distribution | |
| FT+172530BCR | In distribution | |
| FT+153230BCR | In distribution | |
| FT+152540BC | In distribution | |
| FT+152530BC | In distribution | |
| FT+153230BC | In distribution | |
| FT+163230TP | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071145 | 2007-09-07 |
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.