Catalog Number

-

Brand Name

EDA Module Kit

Version/Model Number

017354

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

-

Product Code

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

2ba84fda-91fe-4b26-abbd-6fc2c1d0f318

Public Version Date

May 13, 2020

Public Version Number

1

DI Record Publish Date

May 05, 2020

Package DI Number

37630039301720

Quantity per Package

1

Contains DI Package

17630039301726

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box