Denver

Basic Information

• Brand Name: Denver
• Primary DI: 10885403075995
• Version / Model: 42-2000
• Catalog Number: 42-2000
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: bc33642c-da3b-4692-800c-29309bc1dd08

Device Description

DENVER™ ASCITES SHUNT DOUBLE-VALVED

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• PM Exempt: No
• 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
KPM	Shunt, Peritoneal	Gastroenterology, Urology	876.5955	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13589	Peritoneovenous shunt	A sterile, surgically implanted, subcutaneous plastic tube used to continuously drain ascites fluid from the peritoneal cavity to the jugular vein. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403075993	GS1	Case	5
Primary	10885403075995	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Number of Valves: 2
Catheter Gauge	15.5	French