EV1000
Pressure Controller Cuff Connector CAP
5manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K140312 |
| Record published | 2016-09-03 |
| Record revised | 2021-11-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE. |
| Packaging | Shipper of 5, shipper of 4 |
| Sizes | Length 3 to 12 ft; length 10 to 51 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PC2B | SIZED FOR USE WITH THE EDWARDS EV1000 NI PRESSURE CONTROLLER (MODEL PC) | In distribution | |
| EVHRSBP | SIZED FOR USE WITH THE EDWARDS EV1000 HEART REFERENCE SENSOR (MODEL EVHRS) | 25 | In distribution |
| EVNIPCL12 | Length 12 ft | In distribution | |
| PC2K | Weight: 0.35 kg (0.77 lbs), Height: 97mm, Width: 54mm, Depth: 35mm, Cable Length: 3.5m | In distribution | |
| EV1000M | HEIGHT: 226 MM, WIDTH: 296 MM, DEPTH: 58.6 MM, WEIGHT: 2.1 KG (4.6 LBS) | In distribution | |
| PC2CCC | SIZED FOR USE WITH THE EDWARDS EV1000 NI PRESSURE CONTROLLER (MODEL PC) | 25 | In distribution |
| EVNIPCL3 | Length 3 ft | In distribution | |
| EVNIDBAC | Length 51 in | In distribution | |
| EVPMAC | Length 10 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Finapres | Finapres Medical Systems B.V. | 14 |
| Hokanson | D. E. Hokanson, Inc. | 11 |
| Valhalla Scientific, Inc | Valhalla Scientific, Inc. | 9 |
| ReDS System | Sensible Medical Innovations Ltd. | 7 |
| ReDS Pro System | Sensible Medical Innovations Ltd. | 6 |
| Avivo™ | Medtronic, Inc. | 3 |
| ICG cable | Cnsystems Medizintechnik GmbH | 3 |
| ECG cable | Cnsystems Medizintechnik GmbH | 3 |
| PhysioFlow | Manatec | 3 |
| uCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | 3 |
| ReDS Wearable System | Sensible Medical Innovations Ltd. | 3 |
| Flying-V – finger cuff (medium) | Cnsystems Medizintechnik GmbH | 3 |
Showing 12 of 66. All products under Plethysmograph, Impedance
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2019-03-21 | Class I | Use error | Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets. | 22443 | 2023-11-28 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2015-05-18 | Class II | Device Design | Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged. | 1,309 units total (696 units in US) | 2015-11-06 |
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.