Safe N Simple

Basic Information

• Brand Name: Safe N Simple
• Primary DI: 00810040133589
• Version / Model: SNS7610328
• Catalog Number: SNS7610328
• Company Name: SAFE N' SIMPLE LLC
• Labeler DUNS: 807812412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• 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: 7a97847f-4b55-4832-adc7-ff7c1b6aea4a

Device Description

9" Urostomy One Piece Pouch Extended Wear Convex Transparent 1 1/4" Pre Cut Stoma Opening with valve and 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
EXG	Bag, Urine Collecting, Ureterostomy	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
Unit of Use	00810040133572	GS1
Primary	00810040133589	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	9	Inch