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 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com | |
| Phone | +49072229320 |
| info.cp@maquet.com |
Device Dimensions
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| Total Volume | 800 Milliliter |
| Pore Size | 64 Micrometer |
| 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 |
Trademark Results [MACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MACE 90820360 not registered Live/Pending |
American College of Endocrinology, Inc. 2021-07-09 |
 MACE 90197901 not registered Live/Pending |
World Wrestling Entertainment, Inc. 2020-09-21 |
 MACE 88737833 not registered Live/Pending |
MACE SECURITY INTERNATIONAL, INC. 2019-12-23 |
 MACE 88675287 not registered Live/Pending |
MACE SECURITY INTERNATIONAL, INC. 2019-10-31 |
 MACE 88334893 not registered Live/Pending |
Cricket Merchant LLC 2019-03-11 |
 MACE 87630808 not registered Dead/Abandoned |
Cricket Merchant LLC 2017-10-02 |
 MACE 86379838 4726986 Live/Registered |
Battlespace Simulations, Inc. 2014-08-28 |
 MACE 86082924 not registered Dead/Abandoned |
Mace Energy, Inc. 2013-10-04 |
 MACE 81029226 1029226 Dead/Cancelled |
Springboard International Records, Inc. 0000-00-00 |
 MACE 79093117 4173432 Live/Registered |
Mace Limited 2010-12-10 |
 MACE 79068273 3825238 Live/Registered |
ANT Applied New Technologies AG 2009-03-26 |
 MACE 78177267 2913830 Dead/Cancelled |
LTP SPORTS GROUP INC. 2002-10-22 |
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