Catalog Number

-

Brand Name

FLOWTRON ACS800

Version/Model Number

513003

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

K133119

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

cd11c93e-f37d-464b-a1ad-ee82aca8cfd8

Public Version Date

September 05, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-