SansaTM 1000-00
SansaTM 1000-00 is a Class II device made by Huxley Medical, listed in FDA GUDID since 21 Oct 2024 (UDI-DI G2331000000), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberG2331000000 | Date21 Oct 2024 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- SansaTM
- Generic name
- Wearable multiple physiological parameter recorder, reusable
- Model / reference
- 1000-00
- Primary DI / UDI-DI
- G2331000000
- FDA product code
- MNR, BZQ, MWJ
- GMDN term
- Wearable multiple physiological parameter recorder, reusable
- Device class
- Class II
- Regulation number
- 868.2375, 870.2800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).
- LIFESCREEN APNEA by Reynolds Medical, Ltd.
- DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR by Dymedix, Inc.
- CADWELL EASYNET NASAL PRESSURE MODULE by Cadwell Laboratories, Inc.
- ApneaLink Air by Resmed Germany, Inc.
- Onera STS 01.00 ONERA STS1 CHEST by Onera B.V.
- QDC-PRO, AND NOX-RIP by Nox Medical
- APNEALINK, MODEL 22302 by Resmed Germany, Inc.
- Wesper Lab by Wesper, Inc.
- SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 by Healthdyne Technologies, Inc.
- WatchPAT SW by ITAMAR MEDICAL LTD