DEVICE: Waveline Pro+ (00815871021135)

Device Identifier (DI) Information

Waveline Pro+
60146TCB
In Commercial Distribution

Avante
00815871021135
GS1

1
178440426 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
17148 Pulse oximeter, line-powered
A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.
Obsolete 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQA Oximeter
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
DSI Detector And Alarm, Arrhythmia
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
DSK Computer, Blood-Pressure
MLD Monitor, St Segment With Alarm
DSF Recorder, Paper Chart
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)
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DXN System, Measurement, Blood-Pressure, Non-Invasive
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

deb1d3fd-6597-4c5d-9d74-55975371f494
November 10, 2021
6
September 23, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
502-244-4444
devicehelp@dremed.com
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