Brava

Basic Information

• Brand Name: Brava
• Primary DI: 05708932719681
• Version / Model: 12048
• Catalog Number: 12048
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-08
• Public Version: 1
• Public Version Date: 2022-04-18
• Public Version Status: New
• Public Device Record Key: 3190a923-7452-4c68-8999-af0f0b9079f4

Device Description

Brava® Protective Seal. Feel Secure. Thickness 4.2 mm, Diameter Inner 3/4 in,, Diameter Outer 2 1/2 in.

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: MR Safe
• 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
46207	Peristomal/periwound dressing	A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. 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	05708932410212	GS1	Retail Box	10	In Commercial Distribution
Primary	05708932719681	GS1
Package	05708932409445	GS1	Shipper Box	48	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	64	Millimeter
Lumen/Inner Diameter	18	Millimeter
Device Size Text, specify			Thickness - mm 4.2
Device Size Text, specify			Diameter Outer - in 2 1/2
Device Size Text, specify			Diameter Inner - in 3/4

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight.