Identity
- Trade Name
- ActiveCare FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Model / Reference
- ActiveCare calf sleeve Small Pair FDA UDI
Identifiers
- Catalog Number
- A201C-0200-10 FDA UDI
- Primary DI / UDI-DI
- 07290016525403 FDA UDI
- 510(k) Number
- K151377 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Sequential venous compression system inflator 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
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
Yes
FDA UDI
Category: Sequential venous compression system inflator
ActiveCare by Medical Compression System (Dbn) , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sequential venous compression system inflator.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Bio Compression Systems Sequential Circulator Model SC-3008-IS — BIO COMPRESSION SYSTEMS, INC. · Class II
- Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2 — Maxstar Industrial Co., Ltd. · Class II
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Cleared under the same submission
K151377 also covers:
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
- ActiveCare — Medical Compression System (Dbn) , Ltd.
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
- Medical Compression System (Dbn) , Ltd.
Sources (1)
- FDA UDI ce83e087-00bf-4d26-87cb-9e8b45f77674 35 fields · synced Jun 8, 2026