FDA.reportPublic FDA data

FLOWTRON ACS800

Primary DI
05055982700221
Brand
FLOWTRON ACS800
Company
Arjohuntleigh AB
Model
513003OR
Device description
DVT Prevention Compression Pump - FLOWTRON PUMP OPERATING ROOM U
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
K133119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133119000FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTSArjohuntleigh Polska SP Z.O.O.2014-02-28JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055982700221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055982700221050559827002215055982700221

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
355804758
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055982763035Maxi MoveKMCEUN2022-07-29
05055982763042Maxi MoveKMCEUN-D2022-07-29
05055982763059Maxi MoveKMCEXN2022-07-29
05055982763325Maxi MoveKMCEXN-D2022-07-29
05055982764407Maxi MoveKMCLUN2022-07-29
05055982764438Maxi MoveKMCLXNMAS000001-US2022-07-29
05055982764704Maxi MoveKMCLXN-C2022-07-29
05055982764971Maxi MoveKMCLXN-D2022-07-29
05055982766937Maxi MoveKMCSUN2022-07-29
05055982766944Maxi MoveKMCSUN-C2022-07-29
05055982766951Maxi MoveKMCSUN-D2022-07-29
05055982766968Maxi MoveKMCSXE2022-07-29
05055982767231Maxi MoveKMCSXE-C2022-07-29
05055982767507Maxi MoveKMCSXE-D2022-07-29
05055982767781Maxi MoveKMCSXN2022-07-29
05055982768054Maxi MoveKMCSXN-C2022-07-29
05055982768337Maxi MoveKMCSXN-D2022-07-29
05055982794619Maxi AirMAS000001-USMAS000001-US2022-07-30
15059441537295AIRPALAP-028SPNBLHAP-028SPNBLH2026-03-23
15059441537301AIRPALAP-034SPNB AP-034SPNB 2026-03-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
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