Solaris Compatible Reusable Adult Spo2 Finger Sensors (S100a-090103 +3 more)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Reusable SpO2 sensors EUDAMEDSolairs FDA UDISolaris FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- pulse oixmeter sensor ，Reusable EUDAMEDBCI Compatible Adult SpO2 Finger Sensor (0.9m cable) FDA UDINonin Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable) FDA UDINonin Compatible Adult SpO2 Finger Sensor (0.9m Cable) FDA UDIBCI Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable) FDA UDIPhilips Compatible Adult SpO2 Soft-Finger Sensor (1.6m cable) FDA UDI
- Model / Reference
- S200A-090101 EUDAMEDFDA UDIT100A-090110 EUDAMEDFDA UDIS100A-090110 EUDAMEDFDA UDIT200A-090101 EUDAMEDFDA UDIT100A-160087 EUDAMEDFDA UDIT100A EUDAMEDT100A-300061-2 EUDAMEDS100A EUDAMEDS100A-300183(1)K EUDAMEDY300 EUDAMEDY300-090109(C) EUDAMEDS400P EUDAMEDS400P-160118 EUDAMEDT100P EUDAMEDT100P-090103 EUDAMEDT200A EUDAMEDS300A EUDAMEDS300A-300105 EUDAMEDS200A EUDAMEDS200A-300182G EUDAMEDY100 EUDAMEDY100-160087 EUDAMEDS100A-090103(L) EUDAMEDY100-300011(C) EUDAMEDS100A-160087K EUDAMEDS100A-300061-2 EUDAMEDY100-090103 EUDAMEDT100A-300183(1)G EUDAMEDT400P EUDAMEDT400P-160118 EUDAMEDY100-090103(C) EUDAMEDT100P-300110 EUDAMEDS100A-090107-2 EUDAMEDY100-160115-1X(C) EUDAMEDS100P EUDAMEDS100P-090103 EUDAMEDS300A-090106 EUDAMEDS100A-300087 EUDAMEDS400A EUDAMEDS400A-160118K EUDAMEDY100-300011(V) EUDAMEDY100-090103(V) EUDAMEDS100A-300061 EUDAMEDY300-300121(C) EUDAMEDY100-300103(C) EUDAMEDT100A-160131 EUDAMEDW100A/N EUDAMEDW100A/N-090115X(B) EUDAMEDY100- 300183(1)G EUDAMEDT400A EUDAMEDT400A-160118 EUDAMEDS100A-300011 EUDAMEDT100A-090107-2 EUDAMEDS100A-090115-1XK EUDAMEDW400A/N EUDAMEDW400A/N-160118(B) EUDAMEDS100A-090123 EUDAMEDT100A-160103 EUDAMEDS100A-090103 EUDAMEDS400P-160118K EUDAMEDY100-300061-2(C) EUDAMEDS100A-090103K EUDAMEDS100A-160131 EUDAMEDS300A-300046 EUDAMEDS300A-090109 EUDAMEDT100A-090115X EUDAMED
- Description
- BCI Compatible Adult SpO2 Finger Sensor (0.9m cable) FDA UDINonin Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable) FDA UDINonin Compatible Adult SpO2 Finger Sensor (0.9m Cable) FDA UDIBCI Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable) FDA UDIPhilips Compatible Adult SpO2 Soft-Finger Sensor (1.6m cable) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06900234100047 EUDAMEDFDA UDI06900234100177 EUDAMEDFDA UDI06900234100092 EUDAMEDFDA UDI06900234100085 EUDAMEDFDA UDI06900234100115 EUDAMEDFDA UDI06900234101303 EUDAMED06900234102416 EUDAMED06900234102584 EUDAMED06900234101228 EUDAMED06900234100146 EUDAMED06900234100276 EUDAMED06900234103598 EUDAMED06900234100597 EUDAMED06900234103499 EUDAMED06900234101921 EUDAMED06900234103956 EUDAMED06900234100337 EUDAMED06900234100566 EUDAMED06900234102799 EUDAMED06900234101563 EUDAMED06900234101860 EUDAMED06900234103727 EUDAMED06900234100627 EUDAMED06900234101907 EUDAMED06900234100122 EUDAMED06900234100283 EUDAMED06900234100436 EUDAMED06900234102447 EUDAMED06900234102553 EUDAMED06900234102300 EUDAMED06900234100368 EUDAMED06900234102072 EUDAMED06900234101990 EUDAMED06900234100481 EUDAMED06900234100528 EUDAMED06900234103925 EUDAMED06900234101556 EUDAMED06900234100320 EUDAMED06900234101235 EUDAMED06900234104373 EUDAMED06900234102522 EUDAMED06900234100375 EUDAMED06900234103697 EUDAMED06900234100016 EUDAMED06900234102454 EUDAMED06900234101952 EUDAMED06900234102331 EUDAMED06900234100443 EUDAMED06900234100061 EUDAMED06900234101167 EUDAMED06900234100498 EUDAMED
- Basic UDI-DI
- B-06900234101303 EUDAMEDB-06900234102416 EUDAMEDB-06900234102584 EUDAMEDB-06900234101228 EUDAMEDB-06900234100146 EUDAMEDB-06900234100085 EUDAMEDB-06900234100276 EUDAMEDB-06900234103598 EUDAMEDB-06900234100597 EUDAMEDB-06900234100092 EUDAMEDB-06900234103499 EUDAMEDB-06900234101921 EUDAMEDB-06900234103956 EUDAMEDB-06900234100337 EUDAMEDB-06900234100566 EUDAMEDB-06900234102799 EUDAMEDB-06900234101563 EUDAMEDB-06900234101860 EUDAMEDB-06900234103727 EUDAMEDB-06900234100627 EUDAMEDB-06900234100047 EUDAMEDB-06900234101907 EUDAMEDB-06900234100122 EUDAMEDB-06900234100283 EUDAMEDB-06900234100436 EUDAMEDB-06900234102447 EUDAMEDB-06900234102553 EUDAMEDB-06900234100177 EUDAMEDB-06900234102300 EUDAMEDB-06900234100368 EUDAMEDB-06900234102072 EUDAMEDB-06900234101990 EUDAMEDB-06900234100481 EUDAMEDB-06900234100528 EUDAMEDB-06900234103925 EUDAMEDB-06900234101556 EUDAMEDB-06900234100320 EUDAMEDB-06900234101235 EUDAMEDB-06900234100115 EUDAMEDB-06900234104373 EUDAMEDB-06900234102522 EUDAMEDB-06900234100375 EUDAMEDB-06900234103697 EUDAMEDB-06900234100016 EUDAMEDB-06900234102454 EUDAMEDB-06900234101952 EUDAMEDB-06900234102331 EUDAMEDB-06900234100443 EUDAMEDB-06900234100061 EUDAMEDB-06900234101167 EUDAMEDB-06900234100498 EUDAMED
- FDA Product Code
- DQA FDA 510(k)FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMEDPoland EUDAMEDItaly EUDAMEDFrance EUDAMEDSweden EUDAMEDRomania EUDAMEDSlovakia EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
This device is a reusable adult pulse oximetry (SpO₂) finger sensor designed for non-invasive measurement of arterial oxygen saturation and pulse rate. It adheres to the nomenclature for a pulse oximeter sensor and functions by transmitting light through the finger to detect hemoglobin oxygenation levels, providing real-time physiological monitoring.
The sensors are intended for reusable clinical use in hospital, ambulatory, or home healthcare settings and are supplied sterile or non-sterile as indicated by the manufacturer’s instructions. They are classified under the Medical Device Directive (MDD) and hold FDA 510(k) clearance as substantially equivalent, with models differentiated by part numbers (e.g., S100A-090103, S200A-090101). Compatibility with Solaris monitors is specified, and no MRI safety restrictions are noted.
Frequently asked questions
Are these finger sensors designed for single-use or can they be reused in clinical settings?
These sensors are explicitly labeled as reusable for clinical use in hospital, ambulatory, or home healthcare environments. The manufacturer’s instructions will specify whether they are supplied sterile or non-sterile, but the design and FDA clearance indicate they are intended for repeated use with proper cleaning and maintenance.
What types of healthcare settings are these sensors approved for, and how do I know which model to choose?
The sensors are approved for hospital, ambulatory, and home healthcare settings, with compatibility confirmed for use with Solaris monitors. Model selection is based on the part number (e.g., S100A-090103, S200A-090101), which differentiates them—check manufacturer documentation to ensure compatibility with your specific Solaris device model.
Do these sensors have any restrictions on use with other medical equipment, such as MRI machines?
The device data does not mention any MRI safety restrictions, meaning these sensors are not explicitly contraindicated for use in MRI environments. However, always verify compatibility with your facility’s MRI protocols and equipment manufacturers, as risks depend on the specific MRI system and sensor materials.
How do I determine if these sensors are sterile upon receipt, and what should I consider for storage?
Sterility status depends on the manufacturer’s instructions—some shipments may include sterile sensors, while others may require sterilization before first use. Storage conditions should follow the manufacturer’s guidelines to maintain performance, typically involving protection from moisture, extreme temperatures, and contamination. Always refer to the included packaging or instructions for specific storage recommendations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K061931 | Class II | Active |
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Manufacturer
- Manufacturer
- Solaris Medical Technology, Inc.
Sources (57)
- FDA 510(k) K061931 24 fields · synced Sep 18, 2026
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