Catalog Number

CPA00030A

Brand Name

PowerLoc

Version/Model Number

CPA00030A

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

Yes

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

6a9d5957-cec0-4f01-a7d5-86914be83a33

Public Version Date

May 24, 2021

Public Version Number

1

DI Record Publish Date

May 14, 2021

Package DI Number

10801741223171

Quantity per Package

5

Contains DI Package

00801741223174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA