Catalog Number

-

Brand Name

Demax

Version/Model Number

DHD20P

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

Yes

FDA Premarket Submission

K140943,K140943

Product Code

MAV

Product Code Name

Syringe, Balloon Inflation

Public Device Record Key

86f25258-d559-490b-9a8c-d87709f3bf01

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

16943718223242

Quantity per Package

20

Contains DI Package

06943718223245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-