Catalog Number

001163-39F

Brand Name

Filter NRFit

Version/Model Number

001163-39F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 15, 2025

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

K190663,K190663

Product Code

BSN

Product Code Name

FILTER, CONDUCTION, ANESTHETIC

Public Device Record Key

ba419114-a940-4399-ac90-346fa1571b5a

Public Version Date

March 12, 2021

Public Version Number

2

DI Record Publish Date

July 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-