Catalog Number

279-20-036

Brand Name

FiberFlo

Version/Model Number

93022-652

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

K954349

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Public Device Record Key

a7d52732-0aad-4436-8f35-d818844a88f9

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

November 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-