FDA.reportPublic FDA data

ActiveCare

Primary DI
07290016525441
Brand
ActiveCare
Company
MEDICAL COMPRESSION SYSTEM (D.B.N.) LTD.
Model
ActiveCare calf sleeve Large pair
Catalog number
A201C-2200-10
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
17290016525448PackageGS12In Commercial Distribution
27290016525445PackageGS110In Commercial Distribution
07290016525441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001652544817290016525448
2729001652544527290016525445
07290016525441072900165254417290016525441

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system inflatorAn electrically-powered device intended to be 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 applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, 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.

Contacts#

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

Regulatory Flags#

DUNS number
531857886
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
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
27290016525421ActiveCareActiveCare calf sleeve Medium pairA201C-1200-102018-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
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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
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96973521878571BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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96973521878649BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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00672736141649BREGBREG, INC.JOW2026-06-25
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18