The Venous Assist System(DVT-2600) - 3chamber oxford thigh garment (One size) - DAESUNG MAREF CO.,LTD.

Duns Number:688817949

Device Description: 3chamber oxford thigh garment (One size)

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More Product Details

Catalog Number

-

Brand Name

The Venous Assist System(DVT-2600)

Version/Model Number

DS111

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K112677,K112677,K112677,K112677,K112677

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

ee452d46-8411-494c-a4b5-41398df9cd29

Public Version Date

June 24, 2021

Public Version Number

5

DI Record Publish Date

October 18, 2016

Additional Identifiers

Package DI Number

38809315678774

Quantity per Package

4

Contains DI Package

18809315678770

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"DAESUNG MAREF CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 175