CT Expres Patient Set Evo
Basic Information
- Primary DI
- D-640647Q9
- Basic UDI-DI Code
- B-640647Q9
- Reference
- 640647
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Bracco Injeneering SA
Additional Description
he Patient Set Evo is intended to be used with the CT Exprรจs Evo Contrast Media Delivery System, the Bottle Spike A and the Day Set III HP, indicated for controlled automatic venous-side administration of contrast media and saline to human subjects while undergoing examination by means of a computed tomography (CT) scanner, including CT angiography (CTA). The Patient Set Evo is intended for a single patient use only, for no more than 12 hours, and for a maximum of three injections (200 mL per injection) or 200 mL of contrast media, whichever occurs first. After its use with a patient, it must be discarded. The CT Exprรจs Evo contains a non-reuse feature which recognizes and accepts the Patient Set Evo when inserted the first time and rejects it when inserted a second time.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11039014 | MULTIPLE CONTRAST AGENT INJECTORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 598543 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).