Brella CB-1068
GUDID 00860009462212
A single use deactivation container 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 Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container Contaminated waste container| Primary Device ID | 00860009462212 |
| NIH Device Record Key | 77ae1fb6-4afe-42fc-a264-acd539f8f098 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brella |
| Version Model Number | CB-1068 |
| Catalog Number | CB-1068 |
| Company DUNS | 080125402 |
| Company Name | Candesant Biomedical, Inc. |
| Device Count | 1 |
| 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 | |
| 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 |
| 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 |
| 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 | 00860009462212 [Primary] |
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 | 2023-09-29 |
| Device Publish Date | 2023-09-21 |
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 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 |
 BRELLA 87980769 not registered Live/Pending |
Brella Space Corp. 2018-06-11 |
 BRELLA 87956944 not registered Live/Pending |
Brella Space Corp. 2018-06-11 |
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