Catalog Number

158250

Brand Name

HydroMax HMEF

Version/Model Number

HydroMax HMEF - 158250

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130664,K130664

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

33a38c38-f268-4673-bbaf-02db74126faf

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

July 08, 2020

Package DI Number

00817081026726

Quantity per Package

200

Contains DI Package

00817081026719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-