AccessGUDID - DEVICE: Nautilus VF ECMO Oxygentaor (10850007732315)

GUDID

Device Identifier (DI) Information

Brand Name: Nautilus VF ECMO Oxygentaor
Version or Model: 58110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 58110
Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Primary DI Number: 10850007732315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806687406 *Terms of Use

Device Description: The Nautilus VF ECMO Oxygenator is a diffusion polymethylpentene (PMP) membrane oxygenator with BalanceTM Biosurface used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed. The device contains integrated sensors. The following measured parameters can be transmitted to the VitalFlow ECMO Console through the Nautilus VF Oxygenator Cable: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature. The difference between the inlet and outlet pressure, delta pressure, is calculated and also transmitted.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
BYS	Oxygenator, Long Term Support Greater Than 6 Hours

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232767	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c4c1867-6451-44ca-9eaf-0324c0bd2e46
Public Version Date: September 27, 2024
Public Version Number: 1
DI Record Publish Date: September 19, 2024