FDA.reportPublic FDA data

ActiveCare

Primary DI
27290016525490
Brand
ActiveCare
Company
MEDICAL COMPRESSION SYSTEM (D.B.N.) LTD.
Model
ActiveCare Thigh sleeve Medium Pair
Catalog number
A201T-1480-10
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K151377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151377000ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn) , Ltd.2015-07-16JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016525493PackageGS12In Commercial Distribution
27290016525490PackageGS110In Commercial Distribution
07290016525496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001652549317290016525493
2729001652549027290016525490
07290016525496072900165254967290016525496

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system pumpAn electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the sequential inflation and deflation of the multi-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-(800) 377-5804CustomerService@mcsmed.com

Regulatory Flags#

DUNS number
531857886
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290016525370ActiveCare ActiveCare DVTA502B-0001-022017-08-04
17290016525387ActiveCareActiveCare+S.F.TA502B-0001-012017-08-04
17290016525394ActiveCareHomeCare ActiveCare+S.F.TA502B-0002-012017-08-04
07290016525403ActiveCareActiveCare calf sleeve Small Pair A201C-0200-102018-01-05
07290016525410ActiveCareActiveCare calf sleeve+stock Small Pair A201C-020S-102018-01-05
07290016525427ActiveCareActiveCare calf sleeve Medium pairA201C-1200-102018-01-05
07290016525434ActiveCareActiveCare calf sleeve+stock Medium pairA201C-120S-102018-01-05
07290016525441ActiveCareActiveCare calf sleeve Large pairA201C-2200-102018-01-05
07290016525458ActiveCareActiveCare calf sleeve+stock Large pairA201C-220S-102018-01-05
07290016525465ActiveCareActiveCare calf sleeve X-Large pairA201C-4200-102018-01-05
07290016525472ActiveCareActiveCare calf sleeve+stock X-Large pairA201C-420S-102018-01-05
07290016525489ActiveCareActiveCare Thigh sleeve small PairA201T-0480-102018-01-05
07290016525496ActiveCareActiveCare Thigh sleeve Medium PairA201T-1480-102018-01-05
07290016525502ActiveCareActiveCare Thigh sleeve Large PairA201T-2480-102018-01-05
07290016525519ActiveCareActiveCare Foot sleeve PairA201F-1280-102018-01-05
07290016525373ActiveCare ActiveCare DVTA502B-0001-022017-08-04
07290016525380ActiveCareActiveCare+S.F.TA502B-0001-012017-08-04
07290016525397ActiveCareHomeCare ActiveCare+S.F.TA502B-0002-012017-08-04
17290016525400ActiveCareActiveCare calf sleeve Small Pair A201C-0200-102018-01-05
27290016525414ActiveCareActiveCare calf sleeve+stock Small Pair A201C-020S-102018-01-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
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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
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10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
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