Catalog Number

194101

Brand Name

EKM INFLATION DEVICE

Version/Model Number

194101

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

K953522,K953522

Product Code

MAV

Product Code Name

Syringe, Balloon Inflation

Public Device Record Key

bb308c85-0f5b-45d4-ad98-e002a6a0ae01

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

20886333207620

Quantity per Package

5

Contains DI Package

00886333207626

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box