Catalog Number

-

Brand Name

Patient Application Kit with Ear Clip for mature/intact skin

Version/Model Number

PAK-EC

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

K041548,K071672,K101690,K151329,K041548,K071672,K101690,K151329

Product Code

DPZ

Product Code Name

Oximeter, Ear

Public Device Record Key

5d1f9670-2063-4749-8075-23f61d011b45

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 26, 2021

Package DI Number

17640121880954

Quantity per Package

12

Contains DI Package

07640121880957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box