Identity
- Trade Name
- VenaPulse FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- Pneumatic tourniquet to evacuate blood from limb. FDA UDI
- Model / Reference
- VP-25 FDA UDI
- Description
- Pneumatic tourniquet to evacuate blood from limb. FDA UDI
Identifiers
- Catalog Number
- VP-25 FDA UDI
- Primary DI / UDI-DI
- 00860446000329 FDA UDI
- 510(k) Number
- K903894 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Surgical pneumatic tourniquet 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
No
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
No
FDA UDI
Category: Surgical pneumatic tourniquet system
VenaPulse by Aci Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical pneumatic tourniquet system.
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- LiveBand BFR — INNOVATION INSTITUTE, LLC · Class I
- PTSii Personalized Tourniquet System (Red) — Delfi Medical Innovations Inc · Class I
- A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
- DTS-3000 — DAESUNG MAREF CO., LTD. · Class I
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
- Aci Medical, Llc
Sources (1)
- FDA UDI f458e2d7-0343-4d3a-9c2d-aa245c1d83e8 36 fields · synced May 31, 2026