Catalog Number

EVPMAC

Brand Name

EV1000

Version/Model Number

EVPMAC

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

-

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

K140312,K160552

Product Code

DSB

Product Code Name

PLETHYSMOGRAPH, IMPEDANCE

Public Device Record Key

197a3605-531d-4cb7-bd69-1d922cb17f2c

Public Version Date

February 22, 2021

Public Version Number

4

DI Record Publish Date

September 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-