Catalog Number

4020007

Brand Name

HEMO-NATE

Version/Model Number

Filter Set

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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

K781815,K781815

Product Code

FPB

Product Code Name

Filter, Infusion Line

Public Device Record Key

35244ce7-5985-4c23-ae40-dfdf99a8a973

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

H67140200071

Quantity per Package

50

Contains DI Package

H67140200070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box