Adult Tubing Pack With Paragon Adult Maxi PMP Oxygenator
This adult tubing pack is supplied pre-connected to the Paragon Adult Maxi PMP Oxygenator for cardiopulmonary bypass. It supports extracorporeal circulation during procedures lasting no…
This adult tubing pack is supplied pre-connected to the Paragon Adult Maxi PMP Oxygenator for cardiopulmonary bypass. It supports extracorporeal circulation during procedures lasting no more than six hours. The oxygenator is intended for gas exchange in adults and small adults.
Blood passes outside the oxygenator’s hollow-fiber membranes while gas passes through their inner channels. Oxygen diffuses into the blood and carbon dioxide diffuses out. An integrated heat exchanger uses water flowing inside separate non-porous fibers to regulate the blood temperature.
Listed Item
The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
Pre-Connected Assembly
The assembly includes blood-line and gas-line tubing connected to the oxygenator and heat exchanger. Both the oxygenator and tubing pack are supplied sterile for single use.
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 | Chalice Medical Ltd, United Kingdom |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Manufacturer |
| 510(k) | K201642 |
| Record published | 2023-11-07 |
| Record revised | 2024-01-03 (version 2) |
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, serial number |
| Storage | Special storage condition: to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Packaging | Box of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CME40004 | 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®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 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231414 | 2023-11-01 |
| K201642 | 2020-09-18 |
| K191246 | 2020-02-28 |
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.