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

Duns Number:688817949

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

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More Product Details

Catalog Number

-

Brand Name

The Venous Assist System(DVT-2600)

Version/Model Number

DS121

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

3ffbc9b8-ee04-4202-a65d-b0c22ff78c94

Public Version Date

June 30, 2021

Public Version Number

5

DI Record Publish Date

October 18, 2016

Additional Identifiers

Package DI Number

38809315678798

Quantity per Package

4

Contains DI Package

18809315678794

Package Discontinue Date

June 30, 2021

Package Status

Not 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