AeroDVx™, Extra Large Flex Bilateral DV-FXLB

GUDID 00856525007129

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 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.

SUN SCIENTIFIC, INC.

Intermittent venous compression system pump

• Primary Device ID: 00856525007129
• NIH Device Record Key: db58c2a0-e78c-4ef6-b7c4-ffb73b54d7d5
• Commercial Distribution Discontinuation: 2030-10-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroDVx™, Extra Large Flex Bilateral
• Version Model Number: Extra Large Flex Bilateral
• Catalog Number: DV-FXLB
• Company DUNS: 609397224
• Company Name: SUN SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856525007129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183349

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-29
• Device Publish Date: 2021-07-21

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