Basic Information
- Primary DI
- D-06970021438011KQ
- Basic UDI-DI Code
- B-06970021438011KQ
- Reference
- 06970021438011
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- HEDY Medical Device Co.,Ltd.
Additional Description
The Infusion Pump is intended to be used for the controlled administration of fluids. The Infusion Pump is intended for the intravenous infusion. The Infusion Pump is intended to be used in conjunction with legally marketed and compatible intravenous administration sets. The Infusion Pump is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas. And it is not suitable for environments of ambulance and other transportation. The Infusion Pump is intended for use on adults, pediatrics and neonates. The Infusion Pump is intended to be used by trained healthcare professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030301 | INFUSION PUMPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | GCQ0933540002 Rev.00 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).