AccessGUDID - DEVICE: hilite (04250358151640)

GUDID

Device Identifier (DI) Information

Brand Name: hilite
Version or Model: hilite 1000 hollow fiber oxygenator for neonates and infants, model 0001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MW 6208 0001
Company Name: Medos Medizintechnik Aktiengesellschaft

Primary DI Number: 04250358151640
Issuing Agency: GS1
Commercial Distribution End Date: July 29, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 313013477 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTZ	Oxygenator, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df2ef9f1-2d2b-4c36-9805-2fed99dfde0e
Public Version Date: July 30, 2020
Public Version Number: 4
DI Record Publish Date: September 30, 2015