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
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320691MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
08052990320707MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19