Catalog Number

-

Brand Name

MediMax Tech

Version/Model Number

FIT-5

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

K192035,K192035,K192035,K192035

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

6efaff40-72a6-4a14-b44f-fed0c71807e4

Public Version Date

August 11, 2020

Public Version Number

3

DI Record Publish Date

September 03, 2019

Package DI Number

20817325023591

Quantity per Package

4

Contains DI Package

10817325023594

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case