NBM200

Primary DI
17290013386011
Brand
NBM200
Company
ORSENSE LTD
Model
NBM7000
Catalog number
EU0241P
Device description
Non-Invasive Blood Hemoglobin (Hb) Measurement Monitor
Published
2025-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QGUHemoglobin For Donor Testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGUHemoglobin For Donor TestingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290013386011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001338601117290013386011

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
531857316
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290013386028NBM200NBM7000EU0241P2026-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17290013386028NBM200ORSENSE LTDQGU2026-04-26