hilite

Basic Information

• Brand Name: hilite
• Primary DI: 04250358151640
• Version / Model: hilite 1000 hollow fiber oxygenator for neonates and infants, model 0001
• Catalog Number: MW 6208 0001
• Company Name: Medos Medizintechnik Aktiengesellschaft
• Labeler DUNS: 313013477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-30
• Public Version: 4
• Public Version Date: 2020-07-30
• Public Version Status: Update
• Public Device Record Key: df2ef9f1-2d2b-4c36-9805-2fed99dfde0e
• Distribution End Date: 2020-07-29

Device Description

The Medos hilite 1000 oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 0.2 to 1.0 liters per minute.

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: 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
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	870.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17643	Extracorporeal membrane oxygenator	A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04250358153262	GS1		8	Not in Commercial Distribution	2020-07-29
Primary	04250358151640	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius