Device
Monitoring device for physiological measurements within the BPM Plus platform – single unit configuration.
Manufacturer
BIOBEAT TECHNOLOGIES LTD
BIOBEAT TECHNOLOGIES LTD
Model: 2.1.0
Catalog: BB90000200021
DI: 17290020154610
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Monitoring device for physiological measurements within the BPM Plus platform – single unit configuration.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
40c1901b-9d5b-4dfb-b918-e94560393f19
Distribution Status:
In Commercial Distribution
DUNS Number:
532193771
Device Count:
16
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
17290020154610
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07290020154613
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 57960
Name: Multiple physiological parameter spot-check system, clinical
Definition:
An electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser).
FDA Product Codes
DXN
System, Measurement, Blood-Pressure, Non-Invasive
Premarket Submissions
Submission Number:
K241066
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-20
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
70
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
15
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
95
Item #2 - Storage Handling Type:
Handling Environment Humidity