Device
The Telemetry Monitor 5500 is a battery-operated patient worn monitor with a touchscreen display. The Telemetry Monitor 5500 is intended to monitor and record, and to generate alar...
Manufacturer
Philips Medical Systems DMC GmbH
Philips Medical Systems DMC GmbH
Model: Telemetry Monitor 5500 1.4 GHz Radio
Catalog: 867232
DI: 00884838102842
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
The Telemetry Monitor 5500 is a battery-operated patient worn monitor with a touchscreen display. The Telemetry Monitor 5500 is intended to monitor and record, and to generate alarms for, multiple physiological parameters like ECG, SpO2, and respiration rate. It is equipped with a 1.4 GHz radio to enable wireless bi-directional data flow with Philips' Central Station Patient Information Center (PIC) iX.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ec647ec8-b2e1-4b7c-a14c-b03070df85dc
Distribution Status:
In Commercial Distribution
DUNS Number:
314101218
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00884838102842
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36365
Name: Electrocardiography monitoring system receiver
Definition:
An electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).
FDA Product Codes
MHX
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-30
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
60
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling Low - @attributes - Value:
50
Item #2 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling High - @attributes - Value:
106
Item #2 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
5
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
90
Item #3 - Storage Handling Type:
Storage Environment Humidity