DEVICE: Midmark (00841709105821)
Device Identifier (DI) Information
Midmark
IQvitals Zone, w/Nellcor SPO2 and Wirless
In Commercial Distribution
1-200-0350
MIDMARK CORPORATION
IQvitals Zone, w/Nellcor SPO2 and Wirless
In Commercial Distribution
1-200-0350
MIDMARK CORPORATION
IQvitals Zone, Wireless Monitor, with Serenity BP, Exergen TemporalScanner and Nellcor SpO2
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
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? |
---|---|---|---|---|
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 |
---|---|
DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
MWI | MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
FLL | Thermometer, electronic, clinical |
DQA | Oximeter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 12" L x 11.5" W x 2.75" H |
Device Record Status
97faac7a-cb35-4cf1-a6b8-6980420c9d14
January 10, 2022
9
April 07, 2017
January 10, 2022
9
April 07, 2017
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 |
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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
[?]
+1(800)643-6275
support@midmark.com
support@midmark.com