Phlebo Press DVT 760D (US)

Primary DI
07290105879042
Brand
Phlebo Press DVT 760D (US)
Company
MEGO afek Agricultural Cooperative Society Ltd
Model
760D
Catalog number
L10007D4
Device description
The Phlebo Press® DVT system is a pneumatic compression therapy system used to help prevent deep vein thrombosis in patients who may be susceptible. It may also be used to treat conditions as listed in the Indications for Use. The massage action applied by the garments compresses the treated areas to enhance blood flow and reduce stasis. Intermittent and sequential pneumatic compression enhances fibrinolytic activity to reduce the risk of clot formation.
Published
2019-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K172277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172277000Phlebo Press DVT ModelMego Afek AC , Ltd.2017-11-03JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290105879042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290105879042072901058790427290105879042

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7327929677info@lympha-press.com

Regulatory Flags#

DUNS number
514658082
Device count
1
Serial number
true
Manufacturing date on label
true

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