Identity
- Trade Name
- BREG FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- 1 Ice Water Container, 1 12 VDC output and 240 VAC, 60Hz input transformer and 1 C00016 Cold Comp Universal Pad FDA UDI
- Model / Reference
- 100580-000 FDA UDI
- Description
- 1 Ice Water Container, 1 12 VDC output and 240 VAC, 60Hz input transformer and 1 C00016 Cold Comp Universal Pad FDA UDI
Identifiers
- Catalog Number
- 100580-000 FDA UDI
- Primary DI / UDI-DI
- 00672736134023 FDA UDI
- 510(k) Number
- K183702 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 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: Inflatable hot/cold therapy pack/electric pump
Breg by Breg, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183702 also covers:
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
- Breg, Inc.
Sources (1)
- FDA UDI b1c417a4-aabf-4210-ab1e-890f8dc05fe6 36 fields · synced May 31, 2026