Catalog Number

-

Brand Name

DELTAVEN

Version/Model Number

3837372

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

-

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

57970ac3-07e6-4cfe-b19b-d239f4e7a9a4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 19, 2018

Package DI Number

38032248383730

Quantity per Package

20

Contains DI Package

08032248383739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE