UniFuse
UniFuse Infusion System w/ Cooper Wire
5manufacturers in China registered for this device type
84catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K163356 |
| Record published | 2024-09-06 |
| Record revised | 2024-09-09 (version 10) |
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 | Storage environment temperature up to 27 °C |
| Packaging | Box |
| Sizes | Outer diameter 1.43 to 1.71 mm; length 45 to 135 cm; catheter gauge 4 to 5 Fr |
| Distribution end date | 2024-08-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H787124018440 | Outer Diameter 1.71 mm | In distribution |
| H787124018370 | Outer Diameter 1.43 mm | In distribution |
| H787124018080 | Length 90 cm | In distribution |
| H787124018110 | Length 135 cm | In distribution |
| H787124018240 | Outer Diameter 1.43 mm | In distribution |
| H787124018410 | Catheter Gauge 5 Fr | In distribution |
| H787124018150 | Outer Diameter 1.71 mm | In distribution |
| H787124018350 | Catheter Gauge 4 Fr | In distribution |
| H787124018070 | Catheter Gauge 5 Fr | In distribution |
| H787124018010 | Length 45 cm | In distribution |
| H787124018340 | Length 135 cm | In distribution |
| H787124018130 | Catheter Gauge 5 Fr | In distribution |
| H787124018420 | Catheter Gauge 5 Fr | In distribution |
| H787124018430 | Length 90 cm | In distribution |
| H787124018100 | Length 90 cm | In distribution |
| H787124018180 | Catheter Gauge 4 Fr | In distribution |
| H787124018160 | Catheter Gauge 4 Fr | In distribution |
| H787124018270 | Length 45 cm | In distribution |
| H787124018330 | Length 135 cm | In distribution |
| H787124018030 | Length 45 cm | In distribution |
| H787124018200 | Length 135 cm | In distribution |
| H787124018190 | Catheter Gauge 4 Fr | In distribution |
| H787124018210 | Catheter Gauge 4 Fr | In distribution |
| H787124018360 | Length 135 cm | In distribution |
| H787124018040 | Catheter Gauge 5 Fr | In distribution |
| H787124018120 | Outer Diameter 1.71 mm | In distribution |
| H787124018060 | Length 90 cm | In distribution |
| H787124018170 | Outer Diameter 1.43 mm | In distribution |
| H787124018230 | Catheter Gauge 4 Fr | In distribution |
| H787124018050 | Catheter Gauge 5 Fr | In distribution |
| H787124018310 | Length 90 cm | In distribution |
| H787124018090 | Length 90 cm | In distribution |
| H787124018290 | Catheter Gauge 4 Fr | In distribution |
| H787124018320 | Catheter Gauge 4 Fr | In distribution |
| H787124018220 | Catheter Gauge 4 Fr | In distribution |
| H787124018140 | Catheter Gauge 5 Fr | In distribution |
| H787124018380 | Catheter Gauge 5 Fr | In distribution |
| H787124018280 | Length 90 cm | In distribution |
| H787124018020 | Length 45 cm | In distribution |
| H787124018250 | Catheter Gauge 4 Fr | In distribution |
| H787124018300 | Length 90 cm | In distribution |
| H787124018260 | Outer Diameter 1.43 mm | In distribution |
| 12401819 | Length 90 cm | Withdrawn |
| 12401827 | Length 45 cm | Withdrawn |
| 12401841 | Length 45 cm | Withdrawn |
| 12401808 | Length 90 cm | Withdrawn |
| 12401831 | Catheter Gauge 4 Fr | Withdrawn |
| 12401803 | Length 45 cm | Withdrawn |
| 12401829 | Outer Diameter 1.43 mm | Withdrawn |
| 12401801 | Length 45 cm | Withdrawn |
| 12401813 | Length 135 cm | Withdrawn |
| 12401821 | Outer Diameter 1.43 mm | Withdrawn |
| 12401809 | Length 90 cm | Withdrawn |
| 12401832 | Catheter Gauge 4 Fr | Withdrawn |
| 12401823 | Outer Diameter 1.43 mm | Withdrawn |
| 12401822 | Catheter Gauge 4 Fr | Withdrawn |
| 12401812 | Catheter Gauge 5 Fr | Withdrawn |
| 12401810 | Length 90 cm | Withdrawn |
| 12401830 | Length 90 cm | Withdrawn |
| 12401806 | Catheter Gauge 5 Fr | Withdrawn |
| 12401816 | Catheter Gauge 4 Fr | Withdrawn |
| 12401815 | Catheter Gauge 5 Fr | Withdrawn |
| 12401814 | Length 135 cm | Withdrawn |
| 12401805 | Catheter Gauge 5 Fr | Withdrawn |
| 12401807 | Outer Diameter 1.71 mm | Withdrawn |
| 12401834 | Outer Diameter 1.43 mm | Withdrawn |
| 12401818 | Catheter Gauge 4 Fr | Withdrawn |
| 12401843 | Catheter Gauge 5 Fr | Withdrawn |
| 12401838 | Outer Diameter 1.71 mm | Withdrawn |
| 12401804 | Length 45 cm | Withdrawn |
| 12401836 | Catheter Gauge 4 Fr | Withdrawn |
| 12401833 | Length 135 cm | Withdrawn |
| 12401835 | Catheter Gauge 4 Fr | Withdrawn |
| 12401844 | Catheter Gauge 5 Fr | Withdrawn |
| 12401837 | Length 135 cm | Withdrawn |
| 12401811 | Length 135 cm | Withdrawn |
| 12401842 | Outer Diameter 1.71 mm | Withdrawn |
| 12401817 | Catheter Gauge 4 Fr | Withdrawn |
| 12401820 | Catheter Gauge 4 Fr | Withdrawn |
| 12401826 | Catheter Gauge 4 Fr | Withdrawn |
| 12401828 | Length 90 cm | Withdrawn |
| 12401802 | Outer Diameter 1.71 mm | Withdrawn |
| 12401824 | Length 45 cm | Withdrawn |
| 12401825 | Catheter Gauge 4 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
| Deltran | Utah Medical Products, Inc. | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2023-12-18 | Class II | Process control | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. | 7 eaches |
Recalls
3 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2014-08-06 | Class II | Component design/selection | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long). | Domestic: 36 units | 2017-03-27 |
| 2014-08-06 | Class II | Component design/selection | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long). | Domestic: 81 units; Foreign: 13 units | 2017-03-27 |
| 2014-08-06 | Class II | Component design/selection | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long). | Domestic: 70 units; Foreign: 27 units | 2017-03-27 |
| 2010-05-17 | Not classified | Process control | This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire. | 20 units | 2012-07-25 |
| 2010-04-30 | Not classified | Packaging change control | Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a pa | 22 | 2012-07-25 |
| 2010-04-30 | Not classified | Packaging change control | Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a pa | 741 | 2012-07-25 |
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.