Brella

Primary DI
00860009462298
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080125402
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00860009462250BrellaCB-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
00860009462250BrellaCandesant Biomedical, Inc.QVX2023-09-26
00860009462212BrellaCandesant Biomedical, Inc.QVX2023-09-21