Identity
- Trade Name
- AeroWrap™ FDA UDI
- Generic Name
- Sequential venous compression system FDA UDI
- Device Name
- The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg. 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
- Medium Short FDA UDI
- Description
- The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg. 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
- AW-LMB,Short FDA UDI
- Primary DI / UDI-DI
- 00856525007181 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
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: Sequential venous compression system
AeroWrap™ 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™ Flex Extra Large — 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 4c966957-0654-4090-ae26-aad95972da62 37 fields · synced May 30, 2026