Catalog Number

-

Brand Name

SOL-CARE™ Safety Winged Infusion Set

Version/Model Number

253412SI

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

16aa2365-dbde-4a39-8e0f-30b02ef6d622

Public Version Date

November 05, 2018

Public Version Number

2

DI Record Publish Date

July 03, 2018

Package DI Number

10818392018308

Quantity per Package

50

Contains DI Package

00818392018301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box