FDA.reportPublic FDA data

The Venous Assist System

Primary DI
08809315677752
Brand
The Venous Assist System
Company
DAESUNG MAREF CO.,LTD.
Model
DS500
Device description
Calf garment extension pad
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150980000Venous Assist SystemDaesung Maref Co., Ltd.2016-05-12JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809315677759PackageGS120In Commercial Distribution
28809315677756PackageGS1120In Commercial Distribution
08809315677752PrimaryGS10
08809315677745Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880931567775918809315677759
2880931567775628809315677756
08809315677752088093156777528809315677752
08809315677745088093156777458809315677745

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, single-useA non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a single-use device.

Regulatory Flags#

DUNS number
688817949
Device count
2
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809802643956DTS-3000DTSW400-022023-03-09
08809802648494DVT-SERIESDS0312026-02-09
08809802648500DVT-SERIESDS0332026-02-09
18809802648491DVT-SERIESDS0312026-02-09
18809802648507DVT-SERIESDS0332026-02-09
08809802645301SP-1000SP10100-LL2025-12-19
08809802645318SP-1000SP10100-LX2025-12-19
08809802645325SP-1000SP10100-LZ2025-12-19
08809802645462SP-2000SP20100-LL2025-12-19
08809802645479SP-2000SP20100-LX2025-12-19
08809802645486SP-2000SP20100-LZ2025-12-19
08809802646131LX9maxLX9M100-LL2025-12-19
08809802646148LX9maxLX9M100-LX2025-12-19
08809802646155LX9maxLX9M100-LZ2025-12-19
08809802646810DVT-2600DVT3120-DT2025-12-19
08809802646858DVT-4000SDVT4100-DT2025-12-19
08809802645295SP-1000SP101002025-12-19
18809802645308SP-1000SP10100-LL2025-12-19
18809802645315SP-1000SP10100-LX2025-12-19
18809802645322SP-1000SP10100-LZ2025-12-19

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Primary DI, Brand, Company table
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00850031012769AIROSAIROS MEDICAL INCJOW2026-10-09
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00190446979128AIRCASTDJO, LLCJOW2026-08-03
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50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31