FDA.reportPublic FDA data

Criticare

Primary DI
B4388100EP1US0
Brand
Criticare
Company
CRITICARE TECHNOLOGIES, INC.
Model
nGenuity 8100EP1
Device description
nGenuity with CO2 and Printer
Published
2024-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030613000VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100Criticare Systems, Inc.2003-04-17MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B4388100EP1US0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080402199
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B438506DNP3US0Criticare GeminiVitalCare 506DNP32024-07-08
B438506DNVP30Criticare GeminiVitalCare 506DNVP32024-07-08
B438506LNP30Criticare GeminiVitalCare 506LNP32024-07-08
B438506LNVP30Criticare GeminiVitalCare 506LNVP32024-07-08
B438560DNUS0CriticareeQuality 506DN2024-07-08
B4388100E1ST0CriticarenGenuity 8100E1ST2024-07-08
B4388100E1US0CriticarenGenuity 8100E12024-07-08
B4388100EP1ST0CriticarenGenuity 8100EP1ST2024-07-08
B4388100EPST0CriticarenGenuity 8100EPST2024-07-08
B4388100EPUS0CriticarenGenuity 8100EP2024-07-08
B4388100EUS0CriticarenGenuity 8100E2024-07-08
D438506DNBUS0CriticareeQuality 506DNB2024-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070979405FondCircleFondCircle Inc.DXN2026-10-21
00850070979412FondCircleFondCircle Inc.DXN2026-10-21
08719327007136FinapresFinapres Medical Systems B.V.DXN2026-10-21
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDXN2026-10-04
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549919APKAPK Technology Co.,Ltd.DQA2026-03-17
06946725513606APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513613APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513620APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513637APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513644APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513651APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513668APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513675APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513682APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513699APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513705APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513712APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513729APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513736APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513743APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513750APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513767APKAPK Technology Co.,Ltd.DQA2026-03-10