LiDCO

Basic Information

• Brand Name: LiDCO
• Primary DI: 05060110522903
• Version / Model: Li11190
• Catalog Number: Li11190
• Company Name: LIDCO LIMITED
• Labeler DUNS: 345924427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-27
• Public Version: 3
• Public Version Date: 2020-09-01
• Public Version Status: Update
• Public Device Record Key: e5779fd5-26b1-4c16-9b38-d1882801c2e7

Device Description

Licence, Single Usage Fee, LiDCO CNAP

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
DXG	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION	Cardiovascular	870.1435	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33587	General-body orifice lubricant, non-sterile	A non-sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060110522903	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131048	000