Catalog Number

-

Brand Name

Nellcor

Version/Model Number

MAXFASTI

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

K012891,K012891

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

2584348b-6f6d-400f-98fe-88bfae4795b5

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

August 09, 2021

Package DI Number

20884521815466

Quantity per Package

24

Contains DI Package

10884521815469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE