gudid
Primary ID: VHK 11000, Neonatal, Sterile
MACE (UDI VHK 11000, Neonatal, Sterile)
Manufactured by Maquet Cardiopulmonary AG
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MACE - Primary ID VHK 11000, Neonatal, Sterile
Device Regulatory Overview
The MACE (Model/Catalog Number: VHK 11000, Neonatal, Sterile) is a medical device manufactured by Maquet Cardiopulmonary AG. This product is indexed under FDA Product Code / Category Classification DTN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- VHK 11000, Neonatal, Sterile
- Product Code / EMDN
- DTN
- Device Name
- 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.
- Database Sync Date
- 2026-08-09 09:37:59
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of MACE?
The registered manufacturer of record for MACE is Maquet Cardiopulmonary AG.
What is the Primary UDI-DI identifier for MACE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is VHK 11000, Neonatal, Sterile.
What classification code is assigned to this device?
This device is registered under product classification code DTN.
Similar Classification Devices (DTN)
Other Devices by Maquet Cardiopulmonary AG
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