Catalog Number

QJ22A

Brand Name

Pall QPoint® Filter Capsule

Version/Model Number

QJ22A

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

3e9d966f-e050-426e-a229-3763fb128743

Public Version Date

September 06, 2018

Public Version Number

4

DI Record Publish Date

December 20, 2017

Package DI Number

35034480315503

Quantity per Package

2

Contains DI Package

05034480315502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case