| Primary Device ID | 00607567700499 |
| NIH Device Record Key | 4bc83c3e-dc76-46d9-a95e-d98a9c0ead13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultima Stabilizer |
| Version Model Number | OM-2001S |
| Catalog Number | OM-2001S |
| Company DUNS | 022348156 |
| Company Name | MAQUET CARDIOVASCULAR LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607567700499 [Primary] |
| MWS | Stabilizer,Heart |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00607567701281 - VASOVIEW HEMOPRO 3 | 2025-06-30 The Vasoview Hemopro 3 Power Supply is a reusable, AC-powered device intended to be used only with the Vasoview Hemopro 3 Endosc |
| 00607567700475 - Ultima Activator II Drive Mechanism | 2025-06-20 Ultima Activator II Drive Mechanism |
| 00607567700307 - HeartString III Proximal Seal | 2025-02-06 HeartString III Proximal Seal |
| 00607567700468 - Vasoshield | 2025-02-06 Vasoshield Pressure Controlling Syringe |
| 00607567700598 - Axius Coronary Shunt | 2025-02-06 Axius Coronary Shunt |
| 00607567700604 - Axius Coronary Shunt | 2025-02-06 Axius Coronary Shunt |
| 00607567700611 - Axius Coronary Shunt | 2025-02-06 Axius Coronary Shunt |
| 00607567700628 - Axius Coronary Shunt | 2025-02-06 Axius Coronary Shunt |