Medrad® Veris™ 8600 Vital Signs Monitor
"Pediatric Blood Pressure Disposable Cuffs 7-10 in (17-25 cm) (BP CUFF,DISP,17-25CM,VERIS BX QTY 10,MC) (85278231)"
17manufacturers in China registered for this device type
26catalogue numbers in this listing
3recalls 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 | Bayer Medical Care Inc., 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, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K042569 |
| Record published | 2017-06-23 |
| Record revised | 2019-07-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Packaging | Box of 10, box of 30, box of 25, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3010534 | In distribution | |
| 3010469 | In distribution | |
| 3011508 | In distribution | |
| 3010485 | In distribution | |
| 3010468 | In distribution | |
| 3011544 | In distribution | |
| 3010466 | In distribution | |
| 3011507 | In distribution | |
| 3011541 | In distribution | |
| 3010520 | In distribution | |
| 3010467 | In distribution | |
| 3010532 | In distribution | |
| 3011542 | In distribution | |
| 3012636 | In distribution | |
| 3010794 | In distribution | |
| 3010487 | In distribution | |
| 3010533 | In distribution | |
| 3010531 | In distribution | |
| 3012634 | In distribution | |
| 3011468 | In distribution | |
| 3010515 | In distribution | |
| 3010484 | In distribution | |
| 3011543 | In distribution | |
| 3010462 | In distribution | |
| 3010470 | In distribution | |
| 3012635 | 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 |
| Capsule Vitals Plus | Philips North America LLC | 64 |
| Iradimed | Iradimed Corporation | 59 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | GE Medical Systems Information Technologies, Inc. | 44 |
| 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 Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Medrad Mr Inc | 510(k) number | 2013-11-21 | Class II | Device Design | The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor. | 922 units | 2015-03-30 |
| Bayer Medical Care Inc. | 510(k) number | 2013-04-15 | Class II | Device Design | The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. | 1,066 | 2014-04-03 |
| Bayer Medical Care Inc. | 510(k) number | 2006-09-29 | Not classified | Other | Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes | 80 units | 2007-06-20 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-09-29 | Not classified | Other | Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes | 80 units | 2007-06-20 |
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.