Catalog Number

-

Brand Name

Nellcor

Version/Model Number

PEDICAP

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

K944400,K944400,K944400

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

cbdd7ff0-bdbd-43ca-b8fa-d316fa8237c9

Public Version Date

August 31, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884521083912

Quantity per Package

6

Contains DI Package

20884521083919

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK