Catalog Number

-

Brand Name

Covidien DVT Sleeve

Version/Model Number

RM-5330

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

Yes

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

K031559,K031559

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

bc6a375a-68f1-4798-abbc-71d02e9aed6f

Public Version Date

August 02, 2019

Public Version Number

5

DI Record Publish Date

April 14, 2017

Package DI Number

10816317023079

Quantity per Package

5

Contains DI Package

00816317023072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE