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Mace

FDA UDI

Class II (US FDA UDI)

by Maquet Cardiopulmonary AG

Identity

Trade Name
MACE FDA UDI
Generic Name
Cardiotomy reservoir FDA UDI
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. FDA UDI
Model / Reference
VHK 11000, Neonatal, Sterile FDA UDI
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. FDA UDI

Identifiers

Catalog Number
70104.8596 FDA UDI
Primary DI / UDI-DI
04037691576350 FDA UDI
FDA Product Code
DTN FDA UDI
DTP FDA UDI
GMDN Term
Cardiotomy reservoir FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4400 FDA UDI
870.4230 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 800 Milliliter FDA UDI
Pore Size — 64 Micrometer FDA UDI

Mace by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Maquet Cardiopulmonary AG

Sources (1)

  • FDA UDI 3f9d57b3-5085-486b-8218-42ecf173031b 37 fields · synced May 29, 2026