Identity
- Trade Name
- Brella FDA UDI
- Generic Name
- Contaminated waste container FDA UDI
- Device Name
- A ten count (CB-1068) single use deactivation container kit for the deactivation of a skin patch for treatment of hyperhidrosis in a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis FDA UDI
- Model / Reference
- CB-1052 FDA UDI
- Description
- A ten count (CB-1068) single use deactivation container kit for the deactivation of a skin patch for treatment of hyperhidrosis in a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis FDA UDI
Identifiers
- Catalog Number
- CB-1052 FDA UDI
- Primary DI / UDI-DI
- 00860009462243 FDA UDI
- FDA Product Code
- QVX FDA UDI
- GMDN Term
- Contaminated waste container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4425 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 100 Milliliter FDA UDI
Category: Contaminated waste container
Brella by Candesant Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Candesant Biomedical, Inc.
Sources (1)
- FDA UDI 2ae221ad-12ea-494b-9e53-9f447cac449a 37 fields · synced Jun 8, 2026