Phenom™ Catheter
Phenom™ Plus Catheter
5manufacturers in China registered for this device type
103catalogue numbers in this listing
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 | Cathera, Inc., United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Record published | 2016-10-20 |
| Record revised | 2022-10-20 (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, serial number |
| Storage | Special storage condition: Store in a cool, dark, dry place |
| Sizes | Length 105 to 170 cm; lumen/inner diameter 0.017 to 0.0445 in; lumen/inner diameter 0.021 cm |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG13150-0615-2XV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG13150-1015-2JV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11170-0615-2XV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13150-0615-2JV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11170-1030-2SV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11150-1015-2RV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG19120-1015-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG15135-0630-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG19150-0615-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG15135-0615-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG19105-1015-1SV01 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG11150-1015-2SV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13150-1015-2RV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG15150-2050-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG11170-0615-2JV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG19150-0630-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG13170-0615-2JV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG15150-1030-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG19105-0630-1SV01 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG13150-0630-2SV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG13150-0615-2XV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG13150-0615-2RV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG15135-1015-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG11170-1015-2RV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13150-0615-2SV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11150-0615-2XV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11150-0615-2RV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13150-1030-2SV02 | Lumen/Inner Diameter 0.021 cm | Withdrawn |
| FG19105-0630-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG15135-1030-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG19120-1030-1SV01 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG11170-1015-2JV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG19120-0630-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG13170-1015-2JV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11170-1015-2XV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG19135-1015-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG15135-1030-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG13170-0615-2XV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG15150-1015-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG15150-0630-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG13150-1015-2JV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11170-0615-2RV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11170-1015-2RV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13150-1015-2XV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG15150-0615-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG13170-0615-2JV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11170-1015-2JV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13170-0615-2SV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG13170-0615-2RV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG19120-0615-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG13150-1015-2SV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG15150-1015-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG15135-0630-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG19105-1015-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG19135-0630-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG11150-0630-2SV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11170-0630-2SV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11170-0615-2XV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11170-0615-2RV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13170-0630-2SV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG15150-1030-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG19150-1030-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG19120-1030-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG11170-0615-2SV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG19135-1030-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG13150-1015-2RV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG15135-1015-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG11150-0615-2SV02 | Length 150 cm | Withdrawn |
| FG11150-1015-2XV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11170-1015-2SV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11150-0615-2RV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11170-1015-2XV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13170-0615-2XV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11150-1015-2JV02 | Length 150 cm | Withdrawn |
| FG11150-0615-2JV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG19105-0615-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG13170-1030-2SV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11150-1030-2SV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG19135-1030-1SV01 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG15150-0630-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG13150-0615-2JV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG13170-0615-2RV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11150-0615-2XV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG15150-2050-1SV01 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG13150-0615-2RV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11150-1015-2JV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11150-1015-2RV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11170-0615-2SV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG15150-0615-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG19135-0615-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG13170-0615-2SV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG13170-1015-2RV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG19150-1015-1SV02 | Lumen/Inner Diameter 0.0445 in | Withdrawn |
| FG13150-0615-2SV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG13170-1015-2XV02 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11150-1015-2SV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG15135-0615-1SV02 | Lumen/Inner Diameter 0.027 in | Withdrawn |
| FG11150-0615-2SV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG11150-1015-2XV02 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13150-1015-2SV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG13150-1015-2XV01 | Lumen/Inner Diameter 0.021 in | Withdrawn |
| FG11170-1015-2SV01 | Lumen/Inner Diameter 0.017 in | Withdrawn |
| FG13170-1015-2SV02 | Lumen/Inner Diameter 0.021 in | 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 |
| UniFuse | AngioDynamics, Inc. | 84 |
| 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
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.