FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient Monitor M30
DI: 18800003427847
·
Model: M30
·
Mediana.CO.LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Patient Monitor M30
- Primary DI
- 18800003427847
- Version / Model
- M30
- Catalog Number
- M30M-3PXAH
- Company Name
- Mediana.CO.LTD
- Labeler DUNS
- 687879726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-08
- Public Version
- 4
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 9a015a27-fdc3-4006-90b9-451c096dd43c
Device Description
M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), capnography (EtCO2 and InCO2) temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The M30 is suitable for continuous operation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33586 | General-purpose multi-parameter bedside monitor | An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18800003427847 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100217 | 000 |