Catalog Number

-

Brand Name

Nellcor Pulse Oximeter Probe

Version/Model Number

RM-MAX-I

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

K111773,K111773

Product Code

NLF

Product Code Name

Oximeter, Reprocessed

Public Device Record Key

6010c43f-5a21-438b-8d26-e130e311d7dc

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

August 23, 2016

Package DI Number

10816317020559

Quantity per Package

24

Contains DI Package

00816317020552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE