Device
This SpO2 connection cable is intended to be used when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is
Manufacturer
Fysicon B.V.
Fysicon B.V.
Model: QMAPP SpO2 connection cable 300cm
Catalog: 01567083
DI: 08719689142414
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
This SpO2 connection cable is intended to be used when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is
required. SpO2 can be measured with SpO2 monitoring devices, such as a QMAPP hemodynamic monitoring system. The SpO2 connection
cable is specifically intended to be used to connect a SpO2 sensor to the QMAPP amplifier by a health care professional.The sensor is
contraindicated for use on active patients, conditions of motion or for prolonged use.
This SpO2 connection cable is reusable, unless otherwise stated.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
30ced4a7-bc1c-49ed-804f-e98db15aa391
Distribution Status:
In Commercial Distribution
DUNS Number:
404866654
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08719689142414
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67106
Name: Multiple physiological parameter monitoring support kit
Definition:
A collection of noninvasive devices intended to be used in conjunction with a parent physiological parameter monitor for enabling measurement of multiple vital parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), temperature]. It typically includes an inflatable blood pressure cuff, patient temperature probe, and electrical cables for connection to the monitor (e.g., for connecting an ECG lead to the monitor). This is a reusable device.
FDA Product Codes
DSA
Cable, Transducer And Electrode, Patient, (Including Connector)
Premarket Submissions
Submission Number:
K241766
Supplement Number:
000