MACE

Basic Information

• Brand Name: MACE
• Primary DI: 04037691576350
• Version / Model: VHK 11000, Neonatal, Sterile
• Catalog Number: 70104.8596
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 4
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: 3f9d57b3-5085-486b-8218-42ecf173031b

Device Description

Neonatal Venous Hardshell Cardiotomy Reservoir (MACE), non-coated, vacuum-sealed, 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 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTN	RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS	Cardiovascular	870.4400	2
DTP	Defoamer, cardiopulmonary bypass	Cardiovascular	870.4230	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31710	Cardiotomy reservoir	A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691576350	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141432	000

Device Sizes

Type	Value	Unit	Text
Total Volume	800	Milliliter
Pore Size	64	Micrometer