Assura

Basic Information

• Brand Name: Assura
• Primary DI: 00762123020340
• Version / Model: 12996
• Catalog Number: 12996
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 041c3c42-4170-481a-b323-a177afb18038

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
64583	One-piece urostomy bag, open-ended	A one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00762123026052	GS1	Shipper Box	16	In Commercial Distribution
Primary	00762123020340	GS1
Unit of Use	05701780091879	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Descriptive Bag Size Maxi
Device Size Text, specify			Base Plate Type Convex
Device Size Text, specify			Base Plate Precut Start Hole Size - mm 31
Device Size Text, specify			Base Plate Precut Start Hole Size - in 1 1/4