PEDIATRIC URINE COLLECTORS, CLEAN

Basic Information

• Brand Name: PEDIATRIC URINE COLLECTORS, CLEAN
• Primary DI: 10687225793749
• Version / Model: 05001
• Catalog Number: 05001-00-SCB (Y5178897)
• Company Name: PRECISION DYNAMICS CORPORATION
• Labeler DUNS: 008486367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: 798bcbe9-30a8-46d4-8ea8-927fb12f7bc2

Device Description

PEDIATRIC URINE COLLECTORS, CLEAN, 100/Box, 500/Case

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: 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	10687225793749	GS1
Unit of Use	10687225794692	GS1
Package	10687225793589	GS1	Case	500	In Commercial Distribution