Catalog Number

-

Brand Name

Medex

Version/Model Number

MX380P1

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

K940896,K940896

Product Code

MAV

Product Code Name

Syringe, balloon inflation

Public Device Record Key

90f15590-abf6-4432-beb8-ba1b7e13738b

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

October 19, 2016

Package DI Number

50351688507974

Quantity per Package

5

Contains DI Package

10351688507976

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE