Brella

Primary DI
00860009462250
Brand
Brella
Company
Candesant Biomedical, Inc.
Model
CB-1053
Catalog number
CB-1053
Device description
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
Published
2023-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QVXSkin Patch For Treatment Of Hyperhidrosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVXSkin Patch For Treatment Of HyperhidrosisGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009462250PrimaryGS10
00860009462298Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009462250008600094622508600094622500860009462250
00860009462298008600094622988600094622980860009462298

GMDN Terms#

Term, Definition table
TermDefinition
Contaminated waste containerA container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of contaminated and/or otherwise hazardous biological materials (e.g., waste products containing or having been in contact with human blood, sputum, urine and/or faeces). It is not intended to exclusively contain sharps or for in vitro diagnostic purposes. It is typically used with a disposable liner and has a self-closing lid. It is typically identified with a contaminated material symbol on its labelling. The contents will be sent to disposal usually by incineration. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
(223) 667-9328info@candesant.com

Regulatory Flags#

DUNS number
080125402
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009462236BrellaCB-1051CB-10512023-09-29
00860009462243BrellaCB-1052CB-10522023-09-29
00860009462205BrellaCB-1067CB-10672023-09-29
00860009462229BrellaCB-1050CB-10502023-09-29
00860009462274BrellaCB-1051CB-10512023-09-29
00860009462281BrellaCB-1052CB-10522023-09-29
00860009462298BrellaCB-1053CB-10532023-09-26
00860009462212BrellaCB-1068CB-10682023-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009462236BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462243BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462205BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462229BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462274BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462281BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462298BrellaCandesant Biomedical, Inc.QVX2023-09-26
00860009462212BrellaCandesant Biomedical, Inc.QVX2023-09-21