Catalog Number

LI100H

Brand Name

FiberFlo

Version/Model Number

93250-025

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K983126,K983126

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Public Device Record Key

ddb37738-94b9-4a4b-8abc-c64b9e477afa

Public Version Date

August 30, 2022

Public Version Number

5

DI Record Publish Date

June 12, 2018

Package DI Number

30677964031404

Quantity per Package

6

Contains DI Package

00677964031403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case