QUADROX-iD 70106.7840

GUDID 04058863019000

Extracorporeal membrane oxygenator

Primary Device ID	04058863019000
NIH Device Record Key	b822026b-06f3-44ab-a797-f9a15e07b437
Commercial Distribution Status	In Commercial Distribution
Brand Name	QUADROX-iD
Version Model Number	QUADROX-iD Adult, SOFTLINE Coating, without Filter
Catalog Number	70106.7840
Company DUNS	316153865
Company Name	Maquet Cardiopulmonary AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	04058863019000 [Primary]
GS1	04058863019017 [Package] Package: [4 Units] In Commercial Distribution

DTZ	OXYGENATOR, CARDIOPULMONARY BYPASS

Steralize Prior To Use	false
Device Is Sterile	true

04058863019024	QUADROX-iD Adult Diffusion Membrane Oxygenator, BIOLINE coated, without a filter, with a screw
04058863019000	QUADROX-iD Adult Diffusion Membrane Oxygenator, without Filter, NON-COATED, with a screw connec
04037691741161	QUADROX-iD Adult, without filter, SOFTLINE coating, non-sterilized, semi-finished Product.
04037691739335	QUADROX-iD Adult, without filter, BIOLINE Coating, non-sterile, semi-finished product.
04058863299983	QUADROX-iD Pediatric with BIOLINE Coating
04037691576640	016061 Holder arm