Model: 130-00-101-00
DI: 07290117120002
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cde53426-af5a-49a0-a867-e4b0b7e32282
Distribution Status:
In Commercial Distribution
DUNS Number:
600710452
Device Count:
1
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
17290117120047
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07290117120002
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07290117120002
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 66918
Name: Contactless patient status monitor
Definition:
An electronic device designed for professional use in a clinical or homecare setting for contactless intermittent assessment or continuous monitoring of pulse and respiration rates, and bed exit/occupancy, of a patient during rest or mild body movement. It consists of a small unit, similar to a motion sensor, which uses radar-based micro-motion detection from a close distance (<=5ft) [i.e., non-patient-contact] and has integrated interpretive software algorithms to measure and communicate data to a web-based cloud platform for display at a remote centralized patient monitor.
FDA Product Codes
BZQ
Monitor, Breathing Frequency
DRT
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Premarket Submissions
Submission Number:
K212143
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling Low - @attributes - Value:
-40
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value:
176
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
0
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
75
Item #2 - Storage Handling Type:
Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
70
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
106
Item #3 - Storage Handling Type:
Storage Environment Atmospheric Pressure