Essenz
2 catalogue numbers from Perfusion System Monitor, listed by LivaNova Deutschland GmbH, Germany, under Display, Cathode-Ray Tube, Medical. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | LivaNova Deutschland GmbH, Germany |
|---|---|
| FDA product code | DXJ |
| Device type | Display, Cathode-Ray Tube, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2450 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K212003 |
| Record published | 2022-02-24 |
| Record revised | 2024-05-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Perfusion System Monitor | In distribution | |
| Patient Monitor Software | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexxis OR | Barco, Inc | 85 |
| Nexxis | Barco, Inc | 81 |
| Merit Medical® | Merit Medical Systems, Inc. | 67 |
| Vital Signs | Carefusion Finland 320 Oy | 17 |
| Excite™ | Merit Medical Systems, Inc. | 14 |
| Vital Signs™ | AirLife Finland Oy | 12 |
| VantageView™ | St. Jude Medical | 11 |
| Medline Industries, Inc. | Medline Industries, Inc. | 7 |
| Barco | Barco, Inc | 4 |
| Datapad | LivaNova Deutschland GmbH | 3 |
| IntelliVue GuardianSoftware | Philips Medizin Systeme Böblingen GmbH | 3 |
| Connect | LivaNova Deutschland GmbH | 2 |
Showing 12 of 24. All products under Display, Cathode-Ray Tube, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212003 | 2021-11-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.