Catalog Number

-

Brand Name

Entropy

Version/Model Number

GE Entropy sensor, M1038681

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"

-

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

K082540,K082540

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

c95a4d5c-1434-43a9-8646-0487d9a52b44

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 15, 2016

Package DI Number

20840682102951

Quantity per Package

25

Contains DI Package

00840682102957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-