Model: MDSVITALSTT
Catalog: MDSVITALSTT
DI: 10197344213252
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
VSM, BP, SPO2, EAR TEMP
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1eafff2b-aaac-426b-9ec2-66072c2e9d52
Distribution Status:
In Commercial Distribution
DUNS Number:
025460908
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
Device ID:
10197344213252
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 33586
Name: General-purpose multi-parameter bedside monitor
Definition:
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.
FDA Product Codes
MWI
Monitor, physiological, patient (without arrhythmia detection or alarms)
Premarket Submissions
Submission Number:
K153135
Supplement Number:
000