LiDCO Ltd

Basic Information

• Brand Name: LiDCO Ltd
• Primary DI: 05060110521807
• Version / Model: CM 50-001-01
• Catalog Number: Not a catalog item
• Company Name: LIDCO LIMITED
• Labeler DUNS: 345924427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 7
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 1ac0fe36-b9b2-4682-befa-bd655ac5813b

Device Description

Injectate Kit, US, Single

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: 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: 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
DXG	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION	Cardiovascular	870.1435	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060110521804	GS1		5	In Commercial Distribution
Primary	05060110521807	GS1
Package	25060110521801	GS1		10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023960	000

Device Sizes

Type	Value	Unit	Text
Total Volume	10.0	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 35 Degrees Celsius