FDA.reportPublic FDA data

Criticare Gemini

Primary DI
B438506DNVP30
Brand
Criticare Gemini
Company
CRITICARE TECHNOLOGIES, INC.
Model
VitalCare 506DNVP3
Device description
Monitor with DOX SPO2, NIBP, HR, Printer and Temp
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884216000506 NON-INVASIVE VITAL SIGNS MONITORCriticare Systems, Inc.1989-03-16DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B438506DNVP30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, clinicalAn assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it 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
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
B4388100EP1US0CriticarenGenuity 8100EP12024-07-08
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
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
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06946725513743APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513750APKAPK Technology Co.,Ltd.DQA2026-03-10