FDA.reportPublic FDA data

Flowtron

Primary DI
15055982700686
Brand
Flowtron
Company
Arjohuntleigh AB
Model
DVT10S
Device description
DVT Prevention Compression Garment - DVT 10 STERILE CALF
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
Sterile
true
Single use
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
K925717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925717000CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVEHuntleigh Healthcare, Inc.1993-05-07JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15055982700686PrimaryGS10
05055982700689Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505598270068615055982700686
05055982700689050559827006895055982700689

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
5
DM exempt
true
Lot or batch
true
Expiration 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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96973521878427BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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
96973521878533BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878540BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878557BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878564BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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
96973521878601BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878618BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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
06976287180367Compression Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.JOW2026-07-10
00672736141649BREGBREG, INC.JOW2026-06-25
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18