Doppler 811-BTS 24v Foreign
Catalogue number 811-BTS 24V (F), listed by Parks Medical Electronics, Inc., United States, under Flowmeter, Blood, Cardiovascular. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
5recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
| Dongguan Mars Medical Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Parks Medical Electronics, Inc., United States |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 811-BTS 24V (F) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transonic | Transonic Systems, Inc. | 627 |
| SonoTT Vascular Probe | Em-Tec GmbH | 12 |
| BiDop 7 probe | Koven Technology, Inc. | 8 |
| Medistim MiraQ Cardiac System | Medistim ASA | 6 |
| Medistim MiraQ Vascular System | Medistim ASA | 6 |
| FlowMet™ | Medtronic, Inc. | 4 |
| GEM Flow Coupler | Synovis Micro Companies Alliance | 4 |
| CooperSurgical® | Coopersurgical, Inc. | 4 |
| Medistim System Activation Card | Medistim ASA | 3 |
| 811-BL 24V Foreign & Domestic | Parks Medical Electronics, Inc. | 3 |
| Medistim MiraQ Ultimate System | Medistim ASA | 3 |
| Dopplex | Huntleigh Healthcare Ltd. | 3 |
Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2012-08-08 | Class II | Employee error | Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient’s arm instead of into the blood pressure cuff. | 349 units (Domestic: 270 units – Foreign: 79 units) | 2016-08-19 |
| 2007-11-08 | Not classified | Process control | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | 34 units distributed to: 14 hospitals, 2 veterinary clinics/ | 2011-10-13 |
| 2007-11-08 | Not classified | Process control | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | 122 units distributed to: 9 hospitals, 5 distributors, 5 vet | 2011-10-13 |
| 2007-11-08 | Not classified | Process control | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | 1 unit distributed to: Canadian veterinarian hospital on 9/2 | 2011-10-13 |
| 2007-11-08 | Not classified | Process control | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | 4 units distributed to 1 U.S. hospital | 2011-10-13 |
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.