UR-Assure

Basic Information

• Brand Name: UR-Assure
• Primary DI: 10687225301876
• Version / Model: 05001-00-MCF
• Company Name: PRECISION DYNAMICS CORPORATION
• Labeler DUNS: 008486367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2017-10-25
• Public Version: 5
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 1aad356c-de76-46ff-a01b-7b363b101d31

Device Description

Pediatric Urine Collectors, 160MIL, Clean (non-sterile), 50 Qty

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58929	Adhesive paediatric urine collection bag, open-ended	A flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/pre-adolescent paediatric patient. It is designed with an opening for urine drainage and is typically used for urine output measurement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10687225301876	GS1
Unit of Use	80687225301875	GS1