VTI Power Cord: Hospital US
Part Number 108110-US, VTI Power Cord: Hospital US
4manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
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 | Vascular Technology Incorporated, United States |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| Establishment | Manufacturer |
| Record published | 2016-09-20 |
| Record revised | 2025-12-08 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 108110-US | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082870 | 2008-10-28 |
| K031091 | 2003-04-23 |
Recalls
5 of these are 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 |
|---|---|---|---|---|---|
| 2018-06-19 | Class II | Labeling Change Control | Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver | 10 units | 2020-01-30 |
| 2014-05-28 | Class II | Process design | Report of the product penetrating the sterile barrier; this could render the product unsterile. | 25 | 2016-02-11 |
| 2014-05-28 | Class II | Process design | Report of the product penetrating the sterile barrier; this could render the product unsterile. | 34 | 2016-02-11 |
| 2014-05-28 | Class II | Process design | Report of the product penetrating the sterile barrier; this could render the product unsterile. | 164 | 2016-02-11 |
| 2014-05-28 | Class II | Process design | Report of the product penetrating the sterile barrier; this could render the product unsterile. | 147 | 2016-02-11 |
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.