FDA.reportPublic FDA data

ESSENZ

Primary DI
04033817903161
Brand
ESSENZ
Company
LivaNova Deutschland GmbH
Model
Patient Monitor Software
Published
2022-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXJDisplay, Cathode-Ray Tube, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212003000ESSENZ Patient MonitorLivanova Deutschland, GmbH2021-11-10DXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04033817903161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04033817903161040338179031614033817903161

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. The system typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343225272
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04033817904137DeviceHOLDER WITH MAST-CLAMP LONG2026-01-22
04033817904144DeviceCOCKPITARM - VARIABLE HEIGHT2026-01-22
04033817753070XVAC100-120V2015-10-20
04033817900696Electronic Gas Blender10 l/min2015-10-16
04033817900702Electronic Gas Blender5 l/min2015-10-20
04033817900719Electronic Gas Blender2 l/min2015-10-14
04033817752219XTRA100-120V2015-10-16
04033817901693Virtual Kit NumberS5 LUFTBLASENÜBWERWACHUNG APC2024-07-23
04033817900474S5 Mast Roller PumpMRP 1502015-10-14
04033817900481S5 Mast Roller PumpMRP 852015-10-14
04033817900726B-Care5Sensor Module (venous)2015-10-16
04033817900818S5 Mast Roller PumpControl Panel for 1 MRP2015-10-20
04033817901075B-Care5Venous Sensor (complete)2015-10-20
04033817901150InterfaceModule DDD2015-10-20
04033817902423AccessoriesBubble Sensor 3/16“ x 1/16”2023-03-21
04033817902430AccessoriesBubble Sensor 1/4“ x 1/16“2023-03-21
04033817902447AccessoriesBubble Sensor 3/8“ x 3/32“2023-03-21
04033817902454AccessoriesBubble Sensor 1/2“ x 3/32“2023-03-21
04033817902461AccessoriesFlow Sensor 3/16“ x 1/16”2023-03-21
04033817902478AccessoriesFlow Sensor 1/4“ x 1/16“2023-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334062412Nexxis ORBarco NVDXJ2026-04-28
04251303302278CuratOREIZO GmbHDXJ2026-03-02
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXJ2026-02-11
05415334053458BarcoBarco NVDXJ2025-06-04
05415334053472BarcoBarco NVDXJ2025-06-04
05415334053663BarcoBarco NVDXJ2025-06-04
05415334053670BarcoBarco NVDXJ2025-06-04
10889483575710Vital Signs™AirLife Finland OyDXJ2025-03-31
10889483575734Vital Signs™AirLife Finland OyDXJ2025-03-31
10889483575772Vital Signs™AirLife Finland OyDXJ2025-03-31
05415334050815Nexxis ORBarco NVDXJ2024-02-22
05415334050822Nexxis ORBarco NVDXJ2024-02-22
05415334050839Nexxis ORBarco NVDXJ2024-02-22
10193489385625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
40193489385626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
05415334037625Nexxis ORBarco NVDXJ2023-05-25
05415334037632Nexxis ORBarco NVDXJ2023-05-25
05415334037687Nexxis ORBarco NVDXJ2023-05-25
05415334042346Nexxis ORBarco NVDXJ2023-05-25
06970438060003BIGTIDEShenyang Torch-Bigtide Digital Technology Co., Ltd.DXJ2022-09-05
06970438060065BIGTIDEShenyang Torch-Bigtide Digital Technology Co., Ltd.DXJ2022-09-05
05415334039124Nexxis ORBarco NVDXJ2022-07-11
05415334039131Nexxis ORBarco NVDXJ2022-07-11
10884450568658High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-31
20884450387669High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-15
10884450569334Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-03-05
20884450387676High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-04
20884450569720Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-03-04
10884450569297Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-02-28
20884450569317Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-02-28