Brava

Basic Information

• Brand Name: Brava
• Primary DI: 05708932633284
• Version / Model: 12080
• Catalog Number: 12080
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: faf5ac5c-3c0e-4586-b48a-fd0d310f0fc6

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXB	COLLECTOR, OSTOMY	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46205	Secretion/excreta skin cleanser	A non-sterile substance typically used by ostomists or incontinent persons to gently cleanse skin exposed to intestinal secretions (e.g., around a stoma or fistula) or to excreta (urine or faeces). It is typically used to replace cleaning with soap and water which can aggravate the skin causing soreness/inflammation; it may also be used to remove small amounts of adhesive residue or barrier creams. The device is provided in a variety of forms including a solution, sachets, or disposable wipes. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708932634052	GS1	Shipper Box	40	In Commercial Distribution
Primary	05708932633284	GS1
Unit of Use	05708932661614	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged and consult IFU.