None - Reusable Adult SpO2 Sensor for Use with Commander - Solaris Medical Technology, Inc.

Duns Number:527945351

Device Description: Reusable Adult SpO2 Sensor for Use with Commander III device.

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More Product Details

Catalog Number

-

Brand Name

None

Version/Model Number

S100A-090103-6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

9915f14f-33e9-461e-803e-e39b9a4eae52

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

November 10, 2016

Additional Identifiers

Package DI Number

66900234100025

Quantity per Package

125

Contains DI Package

06900234100023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SOLARIS MEDICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1