Catalog Number

-

Brand Name

MEDI

Version/Model Number

ME92000

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JOM

Product Code Name

PLETHYSMOGRAPH, PHOTOELECTRIC, PNEUMATIC OR HYDRAULIC

Public Device Record Key

67a8ec8b-45a4-4957-9557-66079265ad6b

Public Version Date

April 29, 2020

Public Version Number

2

DI Record Publish Date

November 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-