Catalog Number

-

Brand Name

Solitaire™ X-PACK

Version/Model Number

XPACK200

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

K091559,K183022

Product Code

KRA

Product Code Name

Catheter, continuous flush

Public Device Record Key

a9c91759-8dc6-49bf-8ae2-46ef630c2ed2

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

November 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-