DEVICE: ADVANCED PATIENT MONITOR (B510PM2000XLPRO1)
Device Identifier (DI) Information
ADVANCED PATIENT MONITOR
PM-2000XL PRO
In Commercial Distribution
ADVANCED INSTRUMENTATIONS, INC.
PM-2000XL PRO
In Commercial Distribution
ADVANCED INSTRUMENTATIONS, INC.
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 36872 | Multiple vital physiological parameter monitoring system, clinical |
An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.
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FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| DQA | Oximeter |
| MLD | Monitor, St Segment With Alarm |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| FLL | Thermometer, Electronic, Clinical |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| DSK | Computer, Blood-Pressure |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) |
| DSF | Recorder, Paper Chart |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K120631 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
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| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6794bff1-c7ff-4d1d-9294-7bd6bd318949
November 10, 2021
3
April 16, 2020
November 10, 2021
3
April 16, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined