Catalog Number

-

Brand Name

Couch Ergometer ergoselect 12, P unit, Bluetooth

Version/Model Number

192001.PY

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ISD

Product Code Name

Exerciser, Measuring

Public Device Record Key

0f58bbd3-0694-48ea-bad1-eda68bbc1439

Public Version Date

April 30, 2018

Public Version Number

1

DI Record Publish Date

March 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-