Catalog Number

-

Brand Name

Avante/Pacific

Version/Model Number

NSPH3020

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

K100077,K100077,K100077,K100077,K100077,K100077,K100077

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

54b6106d-2b14-4db8-a2dd-0c9826463040

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

January 20, 2020

Package DI Number

16900234100242

Quantity per Package

20

Contains DI Package

06900234100245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box