Catalog Number

-

Brand Name

Nellcor

Version/Model Number

DS100A-1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012891,K012891

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

78eba7c9-ac5e-4a07-a113-036c96c6ceca

Public Version Date

April 12, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10884522042710

Quantity per Package

50

Contains DI Package

30884522042714

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE