Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10888277991323
• Version / Model: UROT1005
• Catalog Number: UROT1005
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 4
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 511a61b6-4b51-40de-bc01-73b5bd32d667

Device Description

PED URNMTR SIL 8FR 3ML TRAY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHR	Catheter care tray	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58925	Catheter-connected paediatric urine collection bag, closed-ended	A flexible plastic pouch designed to connect to a urinary catheter (typically indwelling) to collect discharged urine from an infant/pre-adolescent paediatric patient; it is not designed with an opening for urine drainage. The device is not attached to the patient and is disposed of when full. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40888277991324	GS1		10	In Commercial Distribution
Primary	10888277991323	GS1

Customer Contacts

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