Model: 302-WS380
DI: 00845717012171
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-28
Current Version: 2026-06-05
Description
Trackstar Premium Wrist BP Monitor, Bluetooth
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9d0688c2-3a17-47cc-9013-56a0239a081d
Distribution Status:
In Commercial Distribution
DUNS Number:
830437997
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
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:
00845717012171
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45617
Name: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Definition:
An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.
FDA Product Codes
DXN
System, Measurement, Blood-Pressure, Non-Invasive
Premarket Submissions
Submission Number:
K233130
Supplement Number:
000