Catalog Number

-

Brand Name

Solairs

Version/Model Number

T100A-300110

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

dae5cafb-14b5-4ac0-9fdc-3e12f9f92546

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

June 16, 2017

Package DI Number

56900234100103

Quantity per Package

80

Contains DI Package

06900234100108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box