FDA UDI
In Commercial Distribution
🇺🇸 United States
NBM200
DI: 17290013386011
·
Model: NBM7000
·
ORSENSE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NBM200
- Primary DI
- 17290013386011
- Version / Model
- NBM7000
- Catalog Number
- EU0241P
- Company Name
- ORSENSE LTD
- Labeler DUNS
- 531857316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-12
- Public Version
- 1
- Public Version Date
- 2025-05-20
- Public Version Status
- New
- Public Device Record Key
- 6e254ef4-aa58-455f-9d40-f5c5a39edb4c
Device Description
Non-Invasive Blood Hemoglobin (Hb) Measurement Monitor
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QGU | Hemoglobin For Donor Testing | Hematology | 864.7500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57960 | Multiple physiological parameter spot-check system, clinical | An 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17290013386011 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 158 Degrees Fahrenheit