Identity
- Trade Name
- VenaOne, Charging Station with Battery Set FDA UDI
- Generic Name
- Intermittent venous compression system FDA UDI
- Model / Reference
- 07-0013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00194832000113 FDA UDI
- 510(k) Number
- K200285 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Intermittent 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
MR Unsafe FDA UDI
Category: Intermittent venous compression system
VenaOne, Charging Station with Battery Set by Precision Medical Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intermittent venous compression system.
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- Pulse Carry Case — NORMATEC INDUSTRIES, LP · Class II
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- Pulse Boot — NORMATEC INDUSTRIES, LP · Class II
Cleared under the same submission
K200285 also covers:
- VenaOne, Bulk pack of 20 — Precision Medical Products
- VenaOne, Disposable Wraps, Box of 20 pairs — Precision Medical Products
- VenaOne, Pair — Precision Medical Products
- VenaOne, Pair of Batteries — Precision Medical Products
- VenaOne, Single Device — Precision Medical Products
- VenaOne, Single Disposable Wrap — Precision Medical Products
- VenaOne, Single Replacement Device — Precision Medical Products
- VenaOne, Wrap Extenders — Precision Medical Products
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
- Precision Medical Products
Sources (1)
- FDA UDI 9c883d06-d110-4ff0-b542-e825168e1b2c 33 fields · synced May 30, 2026