Catalog Number

9005SPCN

Brand Name

AdviewII™

Version/Model Number

9005SPCN

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160439

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

c9e7e99c-5c18-48ee-bedb-eef801e3b57f

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

November 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-