Kolibri

Basic Information

• Brand Name: Kolibri
• Primary DI: 05701780271202
• Version / Model: RCJ110
• Catalog Number: RCJ110
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-20
• Public Version: 1
• Public Version Date: 2023-01-30
• Public Version Status: New
• Public Device Record Key: 097645af-6fa7-43fb-b890-bf217f8c7b3d

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: MR Safe
• 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
LJE	CATHETER, NEPHROSTOMY	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
10735	Nephrostomy catheter	A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05701780271219	GS1	Retail Box	5	In Commercial Distribution
Primary	05701780271202	GS1
Package	05701780271226	GS1	Shipper Box	24	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211911	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	10	French