FDA.reportPublic FDA data

NBM200

Primary DI
17290013386028
Brand
NBM200
Company
ORSENSE LTD
Model
NBM7000
Catalog number
EU0241P
Device description
Non-Invasive Blood Hemoglobin (Hb) Measurement Monitor
Published
2026-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQAOximeter
GLYOximeter To Measure Hemoglobin
QGUHemoglobin For Donor Testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
GLYOximeter To Measure HemoglobinHematology2
QGUHemoglobin For Donor TestingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1903220
K142209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1903220
K142209000Pulse oximeter NBM-200Orsense, Ltd.2015-01-16DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290013386028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001338602817290013386028

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check system, clinicalAn electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Regulatory Flags#

DUNS number
531857316
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290013386011NBM200NBM7000EU0241P2025-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
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07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
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06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
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06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
07290016714265SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-09-08
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06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18