Catalog Number

06-00-0904

Brand Name

Ear sensor

Version/Model Number

ES-2414-15 OEM HP/Philips

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

-

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

-

Product Code

DPZ

Product Code Name

Oximeter, Ear

Public Device Record Key

d529a5b3-d6dc-49be-8bdf-0a000e2578a3

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-