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Solairs

FDA UDI

Class II (US FDA UDI)

by Solaris Medical Technology, Inc.

Identity

Trade Name
Solairs FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
BCI Compatible Adult SpO2 Finger Sensor (3.0m cable) FDA UDI
Model / Reference
S200A-300101 FDA UDI
Description
BCI Compatible Adult SpO2 Finger Sensor (3.0m cable) FDA UDI

Identifiers

Primary DI / UDI-DI
06900234100054 FDA UDI
510(k) Number
K061931 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulse oximeter probe, reusable

Solairs by Solaris Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Solaris Medical Technology, Inc.

Sources (1)

  • FDA UDI a573baac-85c3-43ed-9e28-54b9de4f8f6f 34 fields · synced Jun 6, 2026