Brella CB-1053
GUDID 00860009462298
A two 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
Candesant Biomedical, Inc.
Contaminated waste container| Primary Device ID | 00860009462298 |
| NIH Device Record Key | 8aeb8944-ffd7-43c6-9983-89e395ced499 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brella |
| Version Model Number | CB-1053 |
| Catalog Number | CB-1053 |
| Company DUNS | 080125402 |
| Company Name | Candesant Biomedical, Inc. |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com | |
| Phone | (223) 667-9328 |
| info@candesant.com |
Device Dimensions
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009462250 [Primary] |
| GS1 | 00860009462298 [Unit of Use] |
FDA Product Code
| QVX | Skin Patch For Treatment Of Hyperhidrosis |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-04 |
| Device Publish Date | 2023-09-26 |
On-Brand Devices [Brella]
| 00860009462212 | A single use deactivation container for the deactivation of a skin patch for treatment of hyperh |
| 00860009462298 | A two count (CB-1068) single use deactivation container kit for the deactivation of a skin patch |
| 00860009462281 | A ten count (CB-1068) single use deactivation container kit for the deactivation of a skin patch |
| 00860009462274 | Two count (CB-1067) a skin patch for the treatment of hyperhidrosis in a prescription topical pa |
| 00860009462229 | Ten count (CB-1067) a skin patch for the treatment of hyperhidrosis in a prescription topical pa |
| 00860009462205 | A skin patch for treatment of hyperhidrosis in a prescription topical patch that utilizes a chem |
Trademark Results [Brella]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRELLA 98567187 not registered Live/Pending |
Glaser, Morgan 2024-05-24 |
BRELLA 98567187 not registered Live/Pending |
Mehl, Eden 2024-05-24 |
 BRELLA 98098646 not registered Live/Pending |
West, E'Ian 2023-07-24 |
 BRELLA 97552008 not registered Live/Pending |
CONCRIT LLC 2022-08-17 |
 BRELLA 97333965 not registered Live/Pending |
Joyful Pets, Inc. 2022-03-28 |
 BRELLA 90836727 not registered Live/Pending |
Candesant Biomedical, Inc. 2021-07-19 |
 BRELLA 90387545 not registered Live/Pending |
Brella Insurance, Inc. 2020-12-16 |
 BRELLA 90083863 not registered Live/Pending |
Brella Insurance, Inc. 2020-07-30 |
 BRELLA 90083859 not registered Live/Pending |
Brella Insurance, Inc. 2020-07-30 |
 BRELLA 90076228 not registered Live/Pending |
The Brella Group LLC 2020-07-27 |
 BRELLA 90062186 not registered Live/Pending |
Proa Medical, Inc. 2020-07-20 |
 BRELLA 88614074 not registered Live/Pending |
ITS, Inc. 2019-09-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.