FDA.reportPublic FDA data

DVT-SERIES

Primary DI
08809315675710
Brand
DVT-SERIES
Company
DAESUNG MAREF CO.,LTD.
Model
DS222
Device description
SOFT CALF SLEEVE, Medium 2ea, [One polybag]
Published
2021-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K203016000
K203417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203016000DVT-2600Daesung Maref Co., Ltd.2020-12-05JOW
K203417000DVT-4000SDaesung Maref Co., Ltd.2021-03-28JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809315675717PackageGS110In Commercial Distribution
28809315675714PackageGS120In Commercial Distribution
38809315675711PackageGS140In Commercial Distribution
08809315675710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880931567571718809315675717
2880931567571428809315675714
3880931567571138809315675711
08809315675710088093156757108809315675710

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is 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 reusable device.

Regulatory Flags#

DUNS number
688817949
Device count
1
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08809802645332SP-1000SP10100-RL2025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446979128AIRCASTDJO, LLCJOW2026-08-03
50885380194564KendallCardinal Health 200, LLCJOW2026-07-31
50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
96973521878410BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878427BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878434BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878441BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878458BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878465BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878472BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878489BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878496BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878502BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878519BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878526BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878533BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878540BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22