Midas Rex MR8
Case CA875 MR8 Instrument 3/4 DIN Navig
2manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Medtronic Powered Surgical Solutions, United States |
|---|---|
| FDA product code | FMZ |
| Device type | Incubator, Neonatal |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K183644 |
| Record published | 2021-05-21 |
| Record revised | 2022-09-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CA875 | In distribution | |
| CA850 | In distribution | |
| CA850 | In distribution | |
| CA800 | In distribution | |
| CA875 | In distribution | |
| CA800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tarry Probes | Tarry Medical Products, Inc. | 7 |
| Airlife | AirLife Finland Oy | 6 |
| AirLife | Carefusion Finland 320 Oy | 5 |
| Multi-Link™ | AirLife Finland Oy | 3 |
| Access Medical Probes | Tarry Medical Products, Inc. | 3 |
| Advanced Neonatal Incubator | Advanced Instrumentations, Inc. | 2 |
| Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2 |
| Isolette® 8000 plus | Draeger Medical Systems, Inc. | 2 |
| Isolette 8000 Infant Incubator | Draeger Medical Systems, Inc. | 1 |
| Skin Temp Probe, 5mm O.D.(Y) | Atom Medical Corporation | 1 |
| Oxygen Sensor For Dual Incu i, Incu i, V-2200/2100G(2 pcs/set) | Atom Medical Corporation | 1 |
| Caleo | Drägerwerk AG & Co. KGaA | 1 |
Showing 12 of 41. All products under Incubator, Neonatal
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.