Catalog Number

-

Brand Name

Solairs

Version/Model Number

S200A-300101

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

K061931,K061931,K061931,K061931,K061931,K061931

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

a573baac-85c3-43ed-9e28-54b9de4f8f6f

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

June 16, 2017

Package DI Number

56900234100059

Quantity per Package

80

Contains DI Package

06900234100054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box