Catalog Number

-

Brand Name

DOLPHIN

Version/Model Number

0185ND

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)

-

FDA Premarket Submission

K042449,K042449

Product Code

MAV

Product Code Name

Syringe, balloon inflation

Public Device Record Key

20189998-55eb-49dc-b443-6588058e113b

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

23661234017533

Quantity per Package

6

Contains DI Package

03661234017539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-