Safe N Simple

Basic Information

• Brand Name: Safe N Simple
• Primary DI: 00810040132926
• Version / Model: SNS7400234
• Catalog Number: SNS7400234
• Company Name: SAFE N' SIMPLE LLC
• Labeler DUNS: 807812412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 240
• Record Status: Published
• Publish Date: 2023-11-01
• Public Version: 1
• Public Version Date: 2023-11-09
• Public Version Status: New
• Public Device Record Key: 02858359-4d40-4f2d-b6ec-6ddcb846018b

Device Description

8" Closed 2-Piece Pouch Beige 70 mm 2 3/4" Flange with Belt Tabs

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: Yes
• 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
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31067	Multiple-piece intestinal ostomy bag, closed-ended	A plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The base plate remains attached around the stoma, typically for 2 to 3 days, when the pouch is removed and replaced. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810040132902	GS1
Primary	00810040132926	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	8	Inch