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Bio Compression Systems Multi-Flo DVT Model IC-1545-KT
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Bio Compression Systems Multi-Flo DVT Model IC-1545-KT FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Model / Reference
- IC-1545-KT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812311021168 FDA UDI
- 510(k) Number
- K061857 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump 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
No
FDA UDI
Category: Inflatable hot/cold therapy pack/electric pumpIntermittent venous compression system pump
Bio Compression Systems Multi-Flo DVT Model IC-1545-KT by Bio Compression Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Intermittent venous compression system pump.
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Cleared under the same submission
K061857 also covers:
- Bio Compression Systems DVT Calf/Thigh Sleeve Analog Pair — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems DVT Knee High Calf Sleeve Analog Pair — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems Multi-Flo DVT Model IC-1545-F — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems Multi-Flo DVT Model IC-1545-KTC — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems Multi-Flo DVT Model IC-1545-P — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems Multi-Flo DVT Model IC-1545-PSP — BIO COMPRESSION SYSTEMS, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bio Compression Systems, Inc.
Sources (1)
- FDA UDI 86ceb6f4-8fde-4a86-9e18-ca8c5252b8cc 33 fields · synced May 30, 2026