I2S6 Doppler Probe
Catalogue number 9090-7015, listed by Deltex Medical Limited, United Kingdom, under Probe, Blood-Flow, Extravascular. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
3510(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 | Deltex Medical Limited, United Kingdom |
|---|---|
| FDA product code | DPT |
| Device type | Probe, Blood-Flow, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2120 |
| Establishment | Manufacturer |
| 510(k) | K073593 |
| Record published | 2016-09-07 |
| Record revised | 2021-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature -20 to 60 °C |
| Packaging | Kraft cardboard of 5, kraft cardboard of 18, kraft cardboard of 19, kraft cardboard of 20 |
| Sizes | Length 89 cm; depth 50 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9090-7015 | Length 89 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medex | ICU Medical, Inc | 138 |
| Bio-Probe™ | Medtronic, Inc. | 21 |
| Probe, Blood-Flow, Extravascular | Medtronic, Inc. | 10 |
| 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 |
| 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 |
|---|---|
| K142932 | 2015-01-22 |
| K073593 | 2009-01-29 |
| K052989 | 2006-03-08 |
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.