Catalog Number

-

Brand Name

Delta Fly®

Version/Model Number

3681622

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

K140175,K140175,K140175

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

7920e68e-2d18-43a4-af65-252c3219151b

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

58032248368168

Quantity per Package

20

Contains DI Package

38032248368164

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case