Catalog Number

-

Brand Name

Ergoline/PASSION PLUS 40/3 Smart Performance - PF

Version/Model Number

JK 103 / 40-3 AC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 08, 2019

Issuing Agency

In HIBCC

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

K151400

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

b0082860-bf7c-400e-9d92-5dbf13903f7e

Public Version Date

September 09, 2019

Public Version Number

3

DI Record Publish Date

August 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-