Catalog Number

5404

Brand Name

Teleflex/Hudson RCI

Version/Model Number

5404

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K925591,K925591

Product Code

BZR

Product Code Name

Mixer, breathing gases, anesthesia inhalation

Public Device Record Key

198a36a0-ae33-4ef9-8619-f788cf1201f3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 08, 2016

Package DI Number

40884389001913

Quantity per Package

20

Contains DI Package

10884389001912

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case