AeroDVx™, Medium Flex Bilateral - The AeroDVx ™ System is comprised of a gradient - SUN SCIENTIFIC, INC.

Duns Number:609397224

Device Description: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermitten The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for compression therapy or DVT Prophylaxis. The Bilateral system contains two sleeves.The AeroDVx™ gradient compression sleeve is a non-sterile single patient use medical device. The AeroDVx™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg, and attached and unattached sock. An inflation source is attached to the inflation valve on the sleeve. There are two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use.

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More Product Details

Catalog Number

DV-BMF

Brand Name

AeroDVx™, Medium Flex Bilateral

Version/Model Number

Medium Flex Bilateral

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 31, 2030

Issuing Agency

In GS1

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"

Yes

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

K183349

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

94626c80-0454-4dfd-98ba-86052f16fe10

Public Version Date

July 12, 2022

Public Version Number

1

DI Record Publish Date

July 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUN SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 30