FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344104543
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDS600GOM
Catalog number
MDS600GOM
Device description
GARMENT, PORTABLE DVT PUMP,10PR
Published
2025-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K200568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200568000B&J MHP800 Deep Vein Thrombosis (DVT) Prevention SystemB&J Manufacturing , Ltd.2020-07-10JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344104540PackageGS110In Commercial Distribution
10197344104543PrimaryGS10
80197344104542Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734410454020197344104540
1019734410454310197344104543
8019734410454280197344104542

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
2
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
04719893351026WellellWellell Inc.JOW2026-03-17
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184925CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25