Catalog Number

V-175500-13

Brand Name

Jaeger

Version/Model Number

V-175500-13

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2019

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

K081823

Product Code

CCM

Product Code Name

Plethysmograph, Pressure

Public Device Record Key

a4396541-a5c0-43c7-890f-46bf52d4f4f5

Public Version Date

March 16, 2021

Public Version Number

4

DI Record Publish Date

January 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-