DEVICE: EV1000 (00690103190113)
Device Identifier (DI) Information
EV1000
EV1000DB
In Commercial Distribution
EV1000DB
Edwards Lifesciences LLC
EV1000DB
In Commercial Distribution
EV1000DB
Edwards Lifesciences LLC
EV1000 DATABOX ASSEMBLY
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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 |
---|---|
DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
DSB | PLETHYSMOGRAPH, IMPEDANCE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131892 | 000 |
K160552 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE. |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Height: 145 mm, Width: 206 mm, Depth: 64 mm, Weight: 0.9 kg (2.0 lbs) |
Device Record Status
7dde6139-5334-4271-8473-8f21fdaacc46
November 10, 2021
6
September 03, 2016
November 10, 2021
6
September 03, 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
[?]
+1(800)822-9637
tech_support@edwards.com
tech_support@edwards.com