PlasmaFlow - The PlasmaFlow, model PF0001, is intended to be - MANAMED INC

Duns Number:084042331

Device Description: The PlasmaFlow, model PF0001, is intended to be an easy to use portable system,prescribed The PlasmaFlow, model PF0001, is intended to be an easy to use portable system,prescribed by a physician, for use in the home or clinical setting to help preventthe onset of DVT in patients by stimulating blood flow in the extremities(simulating muscle contractions). This device can be used to:Aid in the prevention of DVT;Enhance blood circulation;Diminish post-operative pain and swelling;Reduce wound healing time;Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers,arterial and diabetic leg ulcers, chronic venous insufficiency and reduction ofedema in the lower limbs.The unit can also be used as an aid in the prophylaxis for DVT by persons expectingto be stationary for long periods of time.

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More Product Details

Catalog Number

PF0001

Brand Name

PlasmaFlow

Version/Model Number

ManaMed

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

02750352-c4b6-4224-b8a4-5aa3d032de9c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MANAMED INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 128
2 A medical device with a moderate to high risk that requires special controls. 19