NBM200 EU0241P

GUDID 17290013386011

Non-Invasive Blood Hemoglobin (Hb) Measurement Monitor

ORSENSE LTD

Multiple physiological parameter spot-check system, clinical

• Primary Device ID: 17290013386011
• NIH Device Record Key: 6e254ef4-aa58-455f-9d40-f5c5a39edb4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NBM200
• Version Model Number: NBM7000
• Catalog Number: EU0241P
• Company DUNS: 531857316
• Company Name: ORSENSE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290013386011 [Primary]

FDA Product Code

• QGU: Hemoglobin For Donor Testing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-20
• Device Publish Date: 2025-05-12