Catalog Number

-

Brand Name

CircuFlow

Version/Model Number

5150

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123959

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

bf4667ff-052d-4981-bb3e-38bd7dcad71a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-