QUADROX-i 70104.5381

GUDID 04037691452982

Maquet Cardiopulmonary AG

Extracorporeal membrane oxygenator

• Primary Device ID: 04037691452982
• NIH Device Record Key: 3b92e608-3f10-4a47-9a14-ccb7a91da716
• Commercial Distribution Discontinuation: 2020-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: QUADROX-i
• Version Model Number: Small Adult, BIOLINE
• Catalog Number: 70104.5381
• 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: true
• 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

Customer Support Contacts

• Phone: +49072229320
• Email: info.cp@maquet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691452982 [Package]; Contains: 04037691526539; Package: [4 Units]; Discontinued: 2020-02-01; Not in Commercial Distribution
GS1	04037691526539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132829

FDA Product Code

• DTR: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-03
• Device Publish Date: 2015-10-24

On-Brand Devices [QUADROX-i]

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• 04058863019192: QUADROX-i Small Adult Microporous membrane oxygenator with integrated arterial filter, SOFTLINE
• 04058863019178: QUADROX-i Small Adult Microporous Membrane Oxygenator with integrated arterial filter, BIOLINE c
• 04058863019154: QUADROX-i Adult Microporous Membrane Oxygenator, Adult, SOFTLINE coated, without Filter, with a
• 04058863019086: QUADROX-i Small Adult Microporous Membrane Oxygenator, BIOLINE coated, without filter, with a sc
• 04058863019062: QUADROX-i Small Adult Microporous Membrane Oxygenator, SOFTLINE coated, without filter, with a s
• 04058863018867: QUADROX-i Small Adult HMO 51000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoi
• 04058863018843: QUADROX-i Adult HMO 71000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vac
• 04058863017792: Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adapto
• 04058863017389: QUADROX-i Adult Microporous Membrane Oxygenator with integrated arterial filter, BIOLINE coated,
• 04058863017358: QUADROX-i Adult Microporous membrane oxygenator with integrated arterial filter, SOFTLINE coated
• 04058863007403: QUADROX-i Adult HMO 70000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vac
• 04058863005805: QUADROX-i Small Adult HMO 50000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoi
• 04037692010013: Small Adult, reservoir, filter
• 04037692011362: Small Adult, reservoir
• 04037692009994: Adult, reservoir, filter
• 04037692009987: Adult, reservoir
• 04037692011379: Small Adult, Filter; BIOLINE Coating
• 04037692010532: Small Adult, BIOLINE
• 04037692010563: Small Adult. Filter
• 04037692010556: Small Adult
• 04037692010570: Adult, Filter; BIOLINE Coating
• 04037692010594: Adult, Filter; SOFTLINE Coating
• 04037692010471: Adult
• 04037691965628: Small Adult, reservoir, filter
• 04037691965307: Small Adult, reservoir
• 04037691913032: Adult, reservoir, filter
• 04037691906942: Adult, reservoir
• 04037691843353: Small Adult
• 04037691782089: Adult
• 04037691780542: Pediatric, reservoir
• 04037691780481: Small Adult. Filter
• 04037691780139: Neonatal, reservoir
• 04037691775388: Pediatric, filter, reservoir
• 04037691773414: Neonatal, filter, reservoir
• 04037691770987: Pediatric, filter
• 04037691670171: Pediatric, diffusion, BIOLINE
• 04037691452982: Small Adult, BIOLINE