Identity
- Trade Name
- HYDROVEN FDA UDI
- Generic Name
- Sequential venous compression system FDA UDI
- Device Name
- HYDROVEN 3 PUMP USA FDA UDI
- Model / Reference
- 510003US FDA UDI
- Description
- HYDROVEN 3 PUMP USA FDA UDI
Identifiers
- Catalog Number
- 510003US FDA UDI
- Primary DI / UDI-DI
- 05051968044198 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Sequential venous compression system 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sequential venous compression system
Hydroven by Huntleigh Healthcare , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sequential venous compression system.
- Pulse Boot Set — NORMATEC INDUSTRIES, LP · Class II
- Blue Boot — NORMATEC INDUSTRIES, LP · Class II
- Mueller Sports Medicine — Mueller Sports Medicine, Inc. · Class II
- AeroWrap™ Flex Large — SUN-SCIENTIFIC INC. · Class I
- Pulse Carry Case — NORMATEC INDUSTRIES, LP · Class II
- Rapid Reboot Recovery Products — RAPID REBOOT RECOVERY PRODUCTS · Class II
- Pulse Boot — NORMATEC INDUSTRIES, LP · Class II
- CoreTech — VIVE HEALTH LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huntleigh Healthcare , Ltd.
Sources (1)
- FDA UDI fe087115-5cd1-4f72-b9b4-e13ab90035f7 36 fields · synced Jun 8, 2026