Catalog Number

-

Brand Name

Precision Delivery IV Extension Set

Version/Model Number

PDM60

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

K202672,K202672

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

fc2358a4-7d87-4bf1-af61-a4938a90aa1b

Public Version Date

February 15, 2021

Public Version Number

1

DI Record Publish Date

February 05, 2021

Package DI Number

20634624621033

Quantity per Package

100

Contains DI Package

00634624621039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-