Catalog Number

AK-04550-S

Brand Name

ARROW

Version/Model Number

IPN036978

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

K810962,K810962

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

9ecd6912-93f9-4ff4-9e12-dbc6277509e7

Public Version Date

January 28, 2022

Public Version Number

5

DI Record Publish Date

April 17, 2018

Package DI Number

50801902121696

Quantity per Package

5

Contains DI Package

60801902121693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case