AeroDVx™ Large Flex Bilateral

Primary DI
00856525007815
Brand
AeroDVx™ Large Flex Bilateral
Company
SUN SCIENTIFIC, INC.
Model
Large Flex Bilateral
Catalog number
DV-BLF
Device description
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.
Published
2022-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K183349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183349000AeroDVx SystemSun Scientific, Inc.2019-07-19JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856525007815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856525007815008565250078158565250078150856525007815

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression system pumpAn electrically-powered device 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 with the necessary pressure to promote venous blood flow. This is achieved through the cyclical inflation and deflation of a single-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with 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

Regulatory Flags#

DUNS number
609397224
Device count
1
Lot or batch
true
No natural rubber latex
true

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