Model: TTQ001
DI: 08885021950044
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Distribution End: 2026-05-15
Description
TipTraQ Kit Version: FIN-10010
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f6cff335-fc67-4fa9-ab15-d2c20678f8c2
Distribution Status:
Not in Commercial Distribution
DUNS Number:
659132760
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
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:
08885021950044
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 12391
Name: Wearable multiple physiological parameter recorder, reusable
Definition:
An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.
FDA Product Codes
MNR
Ventilatory Effort Recorder
Premarket Submissions
Submission Number:
K243268
Supplement Number:
000