Rospital Productos Medicos

Basic Information

• Brand Name: Rospital Productos Medicos
• Primary DI: 00812460028377
• Version / Model: AMPSLB04
• Catalog Number: AMPSLB04
• Company Name: ATLAS MEDICAL PRODUCTS LLC
• Labeler DUNS: 013112308
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-29
• Public Version: 1
• Public Version Date: 2020-10-07
• Public Version Status: New
• Public Device Record Key: ae2266bf-db8e-4191-87c9-3f09fedad871

Device Description

URINE BAG, 2000ML, ANTI-REFLUX VALVE, EA.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	876.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47459	Urine monitoring system collector	A sterile receptacle (e.g., a bag) designed to collect a patient's urine as part of a urine monitoring system. It is connected with tubing to the patient's indwelling catheter and is in contact with the system's urine output sensor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10812460028374	GS1	CASE	250	In Commercial Distribution
Primary	00812460028377	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			URINE BAG, 2000ML, ANTI-REFLUX VALVE, EA.