Carescape
Carescape D19KT VER01
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Shandong (1). 2 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 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | KRB |
| Device type | Probe, Thermodilution |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1915 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213336 |
| Record published | 2017-03-15 |
| Record revised | 2024-10-11 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Handling environment temperature 0 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D19KT VER01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VolumeView | Edwards Lifesciences Technology Sarl | 14 |
| PiCCO Catheter | Pulsion Medical Systems SE | 10 |
| Co-SET+ | Edwards Lifesciences Technology Sarl | 10 |
| ICU Medical | ICU Medical, Inc | 9 |
| PiCCO catheter | Maquet Critical Care AB | 5 |
| Critikit™ | Argon Critical Care Systems Singapore PTE. Ltd. | 3 |
| PiCCO Monitoring Kit | Pulsion Medical Systems SE | 3 |
| Criticath(TM) SP5105HL TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
| Adler Instrument Company | Adler, Inc. | 1 |
| Co Module w/ cable & accessory | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Criticath(TM) SP5507S TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
| Criticath(TM) SP5507 TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
Showing 12 of 49. All products under Probe, Thermodilution
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 547 units |
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.