Catalog Number

-

Brand Name

Nellcor Pulse Oximeter Probe

Version/Model Number

RM-D-25

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

K072194,K072194

Product Code

NLF

Product Code Name

Oximeter, Reprocessed

Public Device Record Key

3db5b216-036f-43ab-947f-56ece4d6902e

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

August 23, 2016

Package DI Number

10816317020528

Quantity per Package

24

Contains DI Package

00816317020521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE