Catalog Number

-

Brand Name

Nellcor

Version/Model Number

D25

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

Yes

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

K993637,K993637

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

2f759718-c7b5-4fa5-82e3-e2a5429c129c

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884522000847

Quantity per Package

24

Contains DI Package

30884522000844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE