Catalog Number

-

Brand Name

ArterioFlow

Version/Model Number

7500

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

-

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

K102582,K102582

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

089dce4d-450b-4d4d-abc8-32a5cd0f8ce8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2016

Package DI Number

10879766005409

Quantity per Package

1

Contains DI Package

00879766005402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case