Catalog Number

-

Brand Name

Nellcor

Version/Model Number

EASYCAP II 6

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

K894053,K894053

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

41e455b7-98f7-4699-8dec-1b4dac94d391

Public Version Date

February 03, 2022

Public Version Number

5

DI Record Publish Date

July 31, 2017

Package DI Number

20884521084046

Quantity per Package

6

Contains DI Package

10884521084049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE