Catalog Number

-

Brand Name

PUREFLOW SL

Version/Model Number

NX2000-6

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FKR

Product Code Name

Subsystem, Proportioning

Public Device Record Key

96a7568b-dc49-405b-a91c-1b0d0dc78267

Public Version Date

June 07, 2021

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-