Probe, Blood-Flow, Extravascular
Transducer 95185-003 BIO Probe TX-50P FA
2manufacturers in China registered for this device type
10catalogue numbers in this listing
2510(k) clearances naming this product code
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 |
| RWD Life Science Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DPT |
| Device type | Probe, Blood-Flow, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2120 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K924208 |
| Record published | 2018-02-13 |
| Record revised | 2018-10-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: Do Not Immerse; Storage environment temperature -34 to 66 °C; Storage environment humidity 15 to 95 % RH |
| Sizes | Outer diameter 6.35 to 9.53 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95185-003 | In distribution | |
| 95184-001 | Outer Diameter 9.53 mm | In distribution |
| 95184-002 | In distribution | |
| 95185-001 | In distribution | |
| R95184-01 | In distribution | |
| 95184-003 | In distribution | |
| 95185-001 | Outer Diameter 6.35 mm | In distribution |
| E95184-01 | In distribution | |
| 95185-002 | In distribution | |
| 95184-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medex | ICU Medical, Inc | 138 |
| Bio-Probe™ | Medtronic, Inc. | 21 |
| Moor Instruments Ltd | Moor Instruments Ltd. | 3 |
| Trillium™ Bio-Probe® | Medtronic, Inc. | 2 |
| Trillium™ | Medtronic, Inc. | 2 |
| FloProbe 3/8’’ x 3/8” (Non Sterile) | Movair, Inc. | 1 |
| FloProbe 1/4’’ x 1/4″ (Non Sterile) | Movair, Inc. | 1 |
| FloProbe 1/4’’ x 1/4’’ (Sterile) | Movair, Inc. | 1 |
| I2P24 Doppler Probe | Deltex Medical Limited | 1 |
| I2S6 Doppler Probe | Deltex Medical Limited | 1 |
| moorFLPI-2 Review PC Software | Moor Instruments Ltd. | 1 |
| moorFLPI2- Measurement PC Software | Moor Instruments Ltd. | 1 |
Showing 12 of 17. All products under Probe, Blood-Flow, Extravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132730 | 2014-05-30 |
| K133903 | 2014-04-10 |
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.