Identity
- Trade Name
- AeroWrap™ Flex Large Bilateral FDA UDI
- Generic Name
- Sequential venous compression system FDA UDI
- Device Name
- The AeroWrap ™ Flex System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ Flex gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap™ Flex Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg from the ankle to the knee. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use. FDA UDI
- Model / Reference
- Large Flex Bi FDA UDI
- Description
- The AeroWrap ™ Flex System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ Flex gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap™ Flex Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg from the ankle to the knee. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use. FDA UDI
Identifiers
- Catalog Number
- MSB-LF FDA UDI
- Primary DI / UDI-DI
- 00856525007457 FDA UDI
- 510(k) Number
- K070457 FDA UDI
- FDA Product Code
- MHW FDA UDI
- GMDN Term
- Sequential venous compression system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 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
No
FDA UDI
Over-the-Counter
Yes
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: Sequential venous compression system
AeroWrap™ Flex Large Bilateral by Sun-Scientific Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070457 also covers:
- Aero-Wrap™ Bilateral Kit, Extra Large — SUN-SCIENTIFIC INC.
- Aero-Wrap™ Bilateral Kit, Large — SUN-SCIENTIFIC INC.
- Aero-Wrap™ Bilateral Kit, Medium — SUN-SCIENTIFIC INC.
- Aero-Wrap™ Bilateral Kit, Small — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sun-Scientific Inc.
Sources (1)
- FDA UDI bfb1217a-ce0b-4ac8-ad3f-3ce6c046fc9c 37 fields · synced Jun 8, 2026