Catalog Number

-

Brand Name

CircuFlow

Version/Model Number

D-383M

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

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

a5d120b1-8683-4de9-9cfc-79ad88047b10

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 30, 2016

Package DI Number

10879766005027

Quantity per Package

10

Contains DI Package

00879766005020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case