FDA.reportPublic FDA data

ActiveCare

Primary DI
07290016525397
Brand
ActiveCare
Company
MEDICAL COMPRESSION SYSTEM (D.B.N.) LTD.
Model
HomeCare ActiveCare+S.F.T
Catalog number
A502B-0002-01
Published
2017-08-04
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
false

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
K060146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060146000ACTIVECARE ++ SYSTEMMedical Compression Systems (Dbn) , Ltd.2006-03-08JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016525397Direct MarkingGS10
27290016525391PackageGS16In Commercial Distribution
37290016525398PackageGS112In Commercial Distribution
17290016525394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016525397072900165253977290016525397
2729001652539127290016525391
3729001652539837290016525398
1729001652539417290016525394

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity87 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit86 Degrees Fahrenheit

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
false
Serial number
true
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
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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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
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96973521878557BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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96973521878571BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878588BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878595BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878632BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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