Assura

Basic Information

• Brand Name: Assura
• Primary DI: 05708932135115
• Version / Model: 12818
• Catalog Number: 12818
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: 1a474eb6-870d-499a-90d1-af048024e292

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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
31075	One-piece intestinal ostomy bag, open-ended	A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00762123020500	GS1	Shipper Box	12	In Commercial Distribution
Package	00762123020494	GS1	Retail Box	5	In Commercial Distribution
Primary	05708932135115	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Descriptive Bag Size Post op
Device Size Text, specify			Base Plate Type Flat
Device Size Text, specify			Base Plate Precut Start Hole Size - in 3/8
Device Size Text, specify			Base Plate Max Cut Size - in 2 3/4
Device Size Text, specify			Base Plate Precut Start Hole Size - mm 10
Device Size Text, specify			Base Plate Max Cut Size - mm 70

Storage Conditions

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