Catalog Number

-

Brand Name

FLOWTRON UNIVERSAL

Version/Model Number

507003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2018

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

K010744

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

cbc81c70-949e-4e3e-bfd5-09ac5ed06f9a

Public Version Date

September 05, 2022

Public Version Number

4

DI Record Publish Date

August 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-