FlowMet™
System Serviced Fmet-IM-SYS-S
4manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K192966 |
| Record published | 2021-07-16 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: Altitude -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa; Special storage condition: Relative humidity 20% to 80% noncondensing; Special storage condition: Temperature 32°F to 122°F (0°C to 50°C) |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FMET-IM-RSC | In distribution | |
| FMET-IM-SYS-S | In distribution | |
| FMET-IM-SYS | In distribution | |
| FMET-IM-SENS-5 | 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 |
| 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 |
| VascuChek Transceiver | Remington Medical, Inc. | 2 |
Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular
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.