AccessGUDID - DEVICE: Quadrox-i (04058863017792)

GUDID

Device Identifier (DI) Information

Brand Name: Quadrox-i
Version or Model: SQUADROX-i HMO 70000+ VHK7000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70106.7941
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04058863017792
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adaptor, without Filter; vacuum-tight, non-Coated, Sterile. The QUADROX-i Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter. They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature.

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
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33
DTP	Defoamer, Cardiopulmonary Bypass
DTN	Reservoir, Blood, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132166	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
Total Volume: 335 Milliliter
Weight: 2.930 Kilogram

Device Record Status

Public Device Record Key: 405a4a7a-46fb-492c-bb2a-29ed8250f487
Public Version Date: June 16, 2020
Public Version Number: 5
DI Record Publish Date: March 13, 2017