Catalog Number

-

Brand Name

ARC Medical

Version/Model Number

5010F

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

-

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

4bd4754d-afb9-47d9-a1e5-cf36100d3374

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

August 27, 2021

Package DI Number

10810050853924

Quantity per Package

50

Contains DI Package

00810050853927

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case