Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 04897122901515
- Basic UDI-DI Code
- B-04897122901515
- Reference
- MD1913
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Fleming Medical Ltd.
Additional Description
The Pulse Oximeter is portable, convenient, non-invasive devices, used for monitor arterial haemoglobin oxygen saturation (Spo2) and pulse rate. The personal application are adult patients (weight: >30kg) and pediatric patients (weight: 20-30kg). We recommend index finger, middle finger and ring finger are suitable position for monitor. It’s intended for spot-checking or attended-care monitoring in Home Health Care and Medical Facility.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1203020302 | NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS |
| Z1203020408 | PULSE OXIMETERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | DD 60147945 0001 | TÜV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇮🇪 Ireland
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