Carescape
Catalogue number Monitor B650-LI, listed by GE Healthcare Finland OY, Finland, under Monitor, Airway Pressure (Includes Gauge And/Or Alarm). 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Fujian (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | CAP |
| Device type | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2600 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K131223 |
| Record published | 2016-07-22 |
| Record revised | 2021-11-10 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH; Handling environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Monitor B650-LI | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 24 |
| Manometer | Mercury Medical Enterprises, LLC | 18 |
| Jaeger | Jaeger Medical GmbH | 9 |
| Vyaire | Jaeger Medical GmbH | 8 |
| Medline Industries, Inc. | Medline Industries, Inc. | 6 |
| Jitto | Galemed Corp. | 6 |
| Napa | DRW Medical | 5 |
| Micro Medical | Jaeger Medical GmbH | 4 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | GE Healthcare Finland OY | 4 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Galemed Corp. | 3 |
| Resuscitator Manometer POP OFF 60cmH2O(PC) | Besmed Health Business Corporation | 2 |
| Cuff Pressure Monitor Assembly | Instrumentation Industries, Incorporated | 2 |
Showing 12 of 44. All products under Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2018-05-25 | Class II | Software design | When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the netwo | 69231 units | |
| GE Medical Systems, LLC | 510(k) number | 2015-05-04 | Class II | Software design | The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an | 110 (83 units US, 27 units OUS) | 2015-09-15 |
| GE Medical Systems, LLC | 510(k) number | 2014-06-13 | Class II | Software design | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor | 41,992 (20,509 US; 21,483 OUS) | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2014-02-28 | Class II | Software design | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues. | 676 units OUS | 2015-04-29 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N83074 | 1985-03-22 | NON-ABSORBABLE BLACK SILK SUTURE | Look, Inc. |
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.