Capiox®fx
FX05
1manufacturer
14catalogue numbers in this listing
16510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Terumo Corp., Japan |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-15 |
| Record revised | 2020-01-22 (version 3) |
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 | Handling environment temperature 1 to 40 °C; Special storage condition: Fragile. This way up. Keep away from sunlight. Keep away from rain. |
| Sizes | Area/surface area 0.5 to 2.5 Square meter |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CX*FX05W | Area/Surface Area 0.5 Square meter | In distribution |
| CX*FX05RE | Area/Surface Area 0.5 Square meter | In distribution |
| CX*FX25RE | Area/Surface Area 2.5 Square meter | In distribution |
| CX*FX15W | Area/Surface Area 1.5 Square meter | In distribution |
| CX*FX25W | Area/Surface Area 2.5 Square meter | In distribution |
| CX*FX15RW40 | Area/Surface Area 1.5 Square meter | In distribution |
| CX*FX05RW | Area/Surface Area 0.5 Square meter | In distribution |
| CX*FX25RW | Area/Surface Area 2.5 Square meter | In distribution |
| CX*FX25E | Area/Surface Area 2.5 Square meter | In distribution |
| CX*FX15E | Area/Surface Area 1.5 Square meter | In distribution |
| CX*FX15RW30 | Area/Surface Area 1.5 Square meter | In distribution |
| CX*FX15RE30 | Area/Surface Area 1.5 Square meter | In distribution |
| CX*FX05E | Area/Surface Area 0.5 Square meter | In distribution |
| CX*FX15RE40 | Area/Surface Area 1.5 Square meter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| Affinity Fusion™ | Medtronic, Inc. | 7 |
| QUADROX-i | Maquet Cardiopulmonary GmbH | 7 |
| Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. | Terumo Cardiovascular Systems Corporation | 6 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130493 | 2013-03-13 |
| K130280 | 2013-03-13 |
| K071572 | 2007-07-23 |
| K071494 | 2007-07-16 |
| K040210 | 2004-03-03 |
| K022115 | 2002-09-27 |
| K993772 | 2000-06-05 |
| K961734 | 1997-07-07 |
| K970463 | 1997-05-06 |
| K960074 | 1996-10-16 |
| K962667 | 1996-10-07 |
| K961000 | 1996-10-02 |
| K922799 | 1993-09-02 |
| K861177 | 1986-05-28 |
| K823125 | 1982-11-24 |
| K812660 | 1981-12-14 |
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.