70100.2233

GUDID 04037691316437

Arterial Cannula, wire reinforced, curved tip with ring

Maquet Cardiopulmonary AG

Cardiopulmonary bypass cannula, arterial

• Primary Device ID: 04037691316437
• NIH Device Record Key: a750f0e8-8320-42cf-94e6-2951815104fd
• Commercial Distribution Discontinuation: 2020-01-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: Art.Can.,reinf.,curved tip w.ring
• Catalog Number: 70100.2233
• 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

Customer Support Contacts

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

Device Dimensions

• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French
• Device Size Text, specify: 0
• Length: 23 Centimeter
• Catheter Gauge: 22 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691085609 [Primary]
GS1	04037691316437 [Package]; Contains: 04037691085609; Package: [10 Units]; Discontinued: 2020-01-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012774

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-10-24

Devices Manufactured by Maquet Cardiopulmonary AG

• 04037691645148 - NA: 2024-12-11 CARDIOHELP Emergency Drive Holder for rail
• 04037691645155 - NA: 2024-12-11 CARDIOHELP Emergency Drive Holder for mast
• 04037691720791 - NA: 2024-12-11 CARDIOHELP Holder for mast
• 04037691002583 - NA: 2024-09-30
• 04037691349190 - BMU 40: 2024-09-30
• 04037691349206 - BMU 40: 2024-09-30
• 04037691349213 - BMU 40: 2024-09-30
• 04037691349220 - BMU 40: 2024-09-30