Catalog Number

-

Brand Name

Precision Delivery IV Extension Set

Version/Model Number

PDFL

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

K202672,K202672

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

f212008d-20ad-4821-8e3a-df6fcff252f8

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Package DI Number

20634624921423

Quantity per Package

50

Contains DI Package

00634624921429

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-