Capsule Vitals Plus
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen Capno Masimo
17manufacturers in China registered for this device type
64catalogue numbers in this listing
13recalls on this code
Who Else Makes It
Concentrated in Guangdong (10), Beijing (2), Jiangsu (1). 8 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 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Armorlink SH Corp | Shanghai | Shanghai | Contract manufacturer | 2 |
| Tontec Precision Plastics Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
Showing 12 of 17. All 17 manufacturers in China registered for Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Record
| Listed by | Philips North America LLC, United States |
|---|---|
| FDA product code | MWI |
| Device type | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K210204 |
| Record published | 2022-03-02 |
| Record revised | 2023-08-14 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 501 |
| SmartLinx Vitals Plus | Philips North America LLC | 174 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 154 |
| Iradimed | Iradimed Corporation | 59 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | GE Medical Systems Information Technologies, Inc. | 44 |
| Medrad® Veris™ 8600 Vital Signs Monitor | Bayer Medical Care Inc. | 26 |
| Xper Flex Cardio Physiomonitoring System | Philips DS North America LLC | 24 |
| Wvsm Wireless Vital Signs Monitor | Athena GTX | 23 |
| 740 Select | ZOE Medical, Inc. | 20 |
| Wvsm Pro, Wireless Vital Signs Monitor Professional | Athena GTX | 20 |
| BioStamp nPoint™ | Medidata Solutions, Inc. | 19 |
| BioStamp nPoint™ | Mc10, Inc. | 18 |
Showing 12 of 314. All products under Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Recalls
11 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-09-06 | Class II | Under Investigation by firm | Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue. | 115 US; 193 ROW | |
| 2022-02-22 | Class II | Under Investigation by firm | When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher | 77 | 2024-11-06 |
| 2021-03-29 | Class II | Software design | Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper | 9208 units WW | |
| 2020-06-18 | Class II | Nonconforming Material/Component | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the batte | 118 units | 2023-01-10 |
| 2020-06-18 | Class II | Nonconforming Material/Component | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the batte | 9,705 units | 2023-01-10 |
| 2020-06-18 | Class II | Nonconforming Material/Component | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the batte | 24,545 Units | 2023-01-10 |
| 2020-04-13 | Class II | Under Investigation by firm | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. | 1075 Units | 2023-04-14 |
| 2020-04-13 | Class II | Under Investigation by firm | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. | 2360 Units | 2023-04-14 |
| 2020-02-20 | Class II | Labeling design | Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are incorrect for custom | 2214 units | 2021-09-21 |
| 2015-06-17 | Class II | Labeling False and Misleading | The device’s labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esop | 697 devices. | 2019-10-02 |
| 2012-08-10 | Class II | Device Design | Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron | 12,448 units | 2015-04-22 |
| 2010-08-25 | Not classified | Software design | Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lo | 3,144 Capsule Neuron UMPC units | 2012-03-20 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 25 | 2016-12-08 |
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.