Catalog Number

-

Brand Name

Demax

Version/Model Number

DIDP30S

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"

Yes

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

K140943,K140943

Product Code

MAV

Product Code Name

Syringe, Balloon Inflation

Public Device Record Key

55d483d8-1ca9-4fec-bc30-854c4418ed66

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

August 09, 2019

Package DI Number

16943718206061

Quantity per Package

20

Contains DI Package

06943718206064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-