FDA.reportPublic FDA data

Criticare

Primary DI
D438506DNBUS0
Brand
Criticare
Company
CRITICARE TECHNOLOGIES, INC.
Model
eQuality 506DNB
Device description
Monitor with DOX SPO2, NIBP, HR with Bluetooth
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
K091050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091050000506CN PATIENT MONITORCriticare Systems, Inc.2009-05-27DRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D438506DNBUS0PrimaryHIBCC0

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
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
B4388100EP1US0CriticarenGenuity 8100EP12024-07-08
B4388100EPST0CriticarenGenuity 8100EPST2024-07-08
B4388100EPUS0CriticarenGenuity 8100EP2024-07-08
B4388100EUS0CriticarenGenuity 8100E2024-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
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09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
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06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
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06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01