BluSat 1295
by OSI Optoelectronics 2 variants
BluSat 1295 is a Class II device made by OSI Optoelectronics, listed in FDA GUDID since 2 Feb 2021 (UDI-DI 30859998006416), 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 | Number30859998006416 | Date2 Feb 2021 | StatusListed |
Official records
- AccessGUDID record 30859998006416
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- BluSat
- Generic name
- Sensor holder, single-use
- Model / reference
- 1295
- Primary DI / UDI-DI
- 30859998006416
- FDA product code
- DQA
- GMDN term
- Sensor holder, single-use
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DQA (Oximeter).
- DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE by Datex-Ohmeda Inc.
- BCI AUTOCON 3304 DIGITAL PULSE OXIMETER by Smiths Medical Pm, Inc.
- EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. by Edentec Corp.
- RD rainbow 4035 by MASIMO CORPORATION
- NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER by Nonin Medical, Inc.
- ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS by Envitec-Wismar GmbH
- rainbow SET 4331 by MASIMO CORPORATION
- NELLCOR(R) N-180 PULSE OXIMETER by Nellcor, Inc.
- PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR by Palco Laboratories, Inc.
- VITALSAT PULSE OXIMETER, MODEL IC32000 by Island Critical Care Corp.