INFUSION PUMPS
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Basic Information
- Primary DI
- 18809220584654
- Basic UDI-DI Code
- B-18809220584654
- Reference
- AS-120 5 kits
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- SOOIL Development Co., Ltd.
Additional Description
he DANA Diabecare RS Insulin Pump is a digitally controlled syringe pump that provides precise insulin delivery and monitoring of device functions. The user-programmable device has two insulin delivery modes, the basal infusion rate and meal bolus doses. The user can also temporarily adjust the basal infusion rate to accommodate changes in activity levels, such as during exercise. The pump is battery-powered, water-resistant, very compact, and weighs only 62 grams.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030301 | INFUSION PUMPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | KR19/81826308 | SGS Belgium NV | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).