DEVICE: Waveline EZ-MAX (00815871021036)
Device Identifier (DI) Information
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? |
|---|---|---|---|---|
| 36898 | Patient monitoring system module, blood gas, transcutaneous |
A small unit dedicated to the measurement of blood gas tensions for the partial pressure of oxygen (pO2) and partial pressure of carbon dioxide (pCO2) transcutaneously (through the skin) in a patient's blood using a special sensor which is typically heated to improve local vascularity. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pO2/pCO2 signals measured and provided by this module.
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Active | false |
| 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.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DSI | Detector And Alarm, Arrhythmia |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| DSK | Computer, Blood-Pressure |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
| MLD | Monitor, St Segment With Alarm |
| FLL | Thermometer, Electronic, Clinical |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K131971 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
529c36fc-03b8-4a4b-a75c-3cb23ac605c8
November 10, 2021
7
September 23, 2016
November 10, 2021
7
September 23, 2016
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
[?]
502-244-4444
devicehelp@dremed.com
devicehelp@dremed.com