VHK reservoir Ad 70106.2604

GUDID 04037691854984

Venous Hardshell Cardiotomy Reservoir, Adult, non-coated, with cardiotomy filter, without screw connector, Sterile. The Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The vacuum-tight version of the VHK reservoir can also be employed postoperatively as drainage and auto-transfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

Maquet Cardiopulmonary AG

Cardiotomy reservoir

• Primary Device ID: 04037691854984
• NIH Device Record Key: 89feef67-17ee-43d7-b64a-ec30697c8688
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VHK reservoir Ad
• Version Model Number: VHK 70000, Venous Reservoir
• Catalog Number: 70106.2604
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691854984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132166

FDA Product Code

• DTP: Defoamer, 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: 2020-01-22
• Device Publish Date: 2017-03-13

Devices Manufactured by Maquet Cardiopulmonary AG

• 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
• 04037691349237 - BMU 40: 2024-09-30
• 04037691349244 - BMU 40: 2024-09-30
• 04037691456584 - NA: 2024-09-30 Wall holder for ambulance. Mandatory for ambulance transportation.