Catalog Number

-

Brand Name

Solaris

Version/Model Number

S100A-090110

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K100077,K100077,K100077,K100077,K100077,K100077

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

30c41114-b7fc-400d-9543-5f2d1acfc2f7

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

December 30, 2016

Package DI Number

56900234100097

Quantity per Package

80

Contains DI Package

06900234100092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-