Inspire
14 catalogue numbers from 7 M, listed by Sorin Group Italia SRL, under Oxygenator, Cardiopulmonary Bypass. 1 manufacturer in China is registered for this product code.
1manufacturer
14catalogue numbers in this listing
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 | Sorin Group Italia SRL |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| 510(k) | K122844 |
| Record published | 2019-08-28 |
| Record revised | 2026-07-06 (version 7) |
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 | Box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7 M | In distribution | |
| 8F M | In distribution | |
| 8F PH.I.S.I.O. | In distribution | |
| 8M | In distribution | |
| 8F DUAL PH.I.S.I.O. | In distribution | |
| 6F M | In distribution | |
| 6F PH.I.S.I.O. | In distribution | |
| HVR | In distribution | |
| 6F DUAL PH.I.S.I.O. | In distribution | |
| 6M | In distribution | |
| 8 DUAL PH.I.S.I.O. | In distribution | |
| HVR DUAL | In distribution | |
| 8 PH.I.S.I.O. | In distribution | |
| 6 PH.I.S.I.O. | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Capiox®fx | Terumo Corp. | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| LivaNova USA, Inc. | UDI-DI | 2018-03-13 | Class II | Incorrect or no expiration date | Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDM | 42 |
| LivaNova USA, Inc. | UDI-DI | 2018-03-13 | Class II | Incorrect or no expiration date | Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDM | 70 |
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.