Catalog Number

-

Brand Name

Minncare HD

Version/Model Number

3031105

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

K133724,K133724

Product Code

NIH

Product Code Name

Disinfectant, Subsystem, Water Purification

Public Device Record Key

deeb99a1-ec39-4518-9933-4775c98c7305

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

January 09, 2018

Package DI Number

30677964079499

Quantity per Package

6

Contains DI Package

00677964079498

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-