Identity
- Trade Name
- AeroDVx ™ FDA UDI
- Generic Name
- Intermittent venous compression system pump FDA UDI
- Device Name
- 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 composed of a family of non-sterile single patient use medical devices. 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. The AeroDVx ™ Gradient Compression Sleeve is available in four sizes and two different lengths (standard and short). The wrap is composed of two polyurethane laminates that are sealed together creating an internal bladder system. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide gradient compression profile when worn and inflated. An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source onto the check valve of pressure opens the leur valve so that the bladder can be inflated or deflated based on the direction of airflow. There will be two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use. FDA UDI
- Model / Reference
- Small, Short, Unilateral FDA UDI
- 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 AeroDVx™ gradient compression sleeve is composed of a family of non-sterile single patient use medical devices. 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. The AeroDVx ™ Gradient Compression Sleeve is available in four sizes and two different lengths (standard and short). The wrap is composed of two polyurethane laminates that are sealed together creating an internal bladder system. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide gradient compression profile when worn and inflated. An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source onto the check valve of pressure opens the leur valve so that the bladder can be inflated or deflated based on the direction of airflow. There will be two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use. FDA UDI
Identifiers
- Catalog Number
- DV-USBS FDA UDI
- Primary DI / UDI-DI
- 00856525007570 FDA UDI
- 510(k) Number
- K183349 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Intermittent venous compression system pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intermittent venous compression system pump
AeroDVx ™ by Sun-Scientific Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183349 also covers:
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
- AeroDVx ™ — SUN-SCIENTIFIC INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sun-Scientific Inc.
Sources (1)
- FDA UDI b7b29a0e-3af7-450c-bfc1-4c7bf247e33d 37 fields · synced May 31, 2026