Flying-V – Finger Cuff (Large)
Unit; Fingersensor for Task Force® Monitor (large); Rectus
5manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Cnsystems Medizintechnik GmbH, Austria |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Manufacturer |
| 510(k) | K014063 |
| Record published | 2018-11-28 |
| Record revised | 2021-11-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 0 to 40 °C; Storage environment humidity 20 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G2.2 | In distribution | |
| G2.3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Finapres | Finapres Medical Systems B.V. | 14 |
| Hokanson | D. E. Hokanson, Inc. | 11 |
| EV1000 | Edwards Lifesciences Technology Sarl | 9 |
| 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 |
Showing 12 of 66. All products under Plethysmograph, Impedance
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K014063 | 2002-02-07 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Partners In Medicine Llc | 510(k) number | 2015-12-01 | Class II | Mixed-up of materials/components | Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects – mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic bl | 28 worldwide 2 monitors distributed in the U.S. | 2017-02-17 |
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.