Catalog Number

-

Brand Name

Nellcor

Version/Model Number

EASYCAP II

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,K894053

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

08ba102b-fd7c-4503-97a2-d7e57c9595ad

Public Version Date

February 03, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

30884521084036

Quantity per Package

4

Contains DI Package

20884521084039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE