MACE 70105.1430

GUDID 04037691665726

Neonatal Venous Hardshell Cardiotomy Reservoir (MACE) neonatal with SOFTLINE Coating, vacuum-tight, Sterile. The Neonatal (VHK 11000) 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. Both reservoirs are of identical design, differing only in the size, to enable the defined performance within flow rates, required for neonatal or pediatric patients. The reservoirs can also be employed postoperatively as drainage and autotransfusion 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: 04037691665726
• NIH Device Record Key: 03f94b4c-8ef6-4101-91d5-2442e918ae23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MACE
• Version Model Number: BO-VHK 11000, SOFTLINE, Neonatal, Sterile
• Catalog Number: 70105.1430
• 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

• Total Volume: 800 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691665726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141432

FDA Product Code

• DTN: RESERVOIR, BLOOD, 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

On-Brand Devices [MACE]

• 04037691665733: Venous Hardshell Cardiotomy Reservoir (MACE) for pediatrics with SOFTLINE Coating, vacuum-tight,
• 04037691665726: Neonatal Venous Hardshell Cardiotomy Reservoir (MACE) neonatal with SOFTLINE Coating, vacuum-tig
• 04037691576350: Neonatal Venous Hardshell Cardiotomy Reservoir (MACE), non-coated, vacuum-sealed, Sterile. The N