Catalog Number

QDS

Brand Name

Pall QPoint® Docking Station Shower

Version/Model Number

QDS

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"

Yes

For Single-Use

Yes

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

K163609,K163609

Product Code

NHV

Product Code Name

System, Water Purification, General Medical Use

Public Device Record Key

06aaddf4-4dd3-484e-8213-5d98f283f07f

Public Version Date

November 28, 2019

Public Version Number

2

DI Record Publish Date

June 26, 2019

Package DI Number

55034480314791

Quantity per Package

1

Contains DI Package

05034480314796

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-