Acrylate Adhesive Strap
Catalogue number FP120-FOT01-004, listed by 1929803 Ontario Corp, under Flowmeter, Blood, Cardiovascular. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
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 | 1929803 Ontario Corp |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| 510(k) | K200337 |
| Record published | 2022-06-17 |
| Record revised | 2025-10-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FP120-FOT01-004 | 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 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 |
|---|---|---|---|---|---|---|
| Flosonics Medical (R/A 1929803 Ontario Corp.) | 510(k) number | 2025-08-07 | Class III | Labeling Change Control | Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. | 9 |
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.