Spictra
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Basic Information
- Primary DI
- 08906172230158
- Basic UDI-DI Code
- B-08906172230158
- Reference
- M7AB
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- No Longer On The Market
- Manufacturer
- MEDIHUB SCIENCETEC PRIVATE LIMITED
Additional Description
A sterile, porous device intended to be used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate matter (e.g., greater than 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device
CND Nomenclature Codes
| Code | Description |
|---|---|
| C03010104 | EXTRACORPOREAL CIRCULATION FILTERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 0068/QPZ-DM/247-2020 | MTIC InterCert S.r.l. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).