FDA UDI
In Commercial Distribution
🇺🇸 United States
FerriScan Phantom
DI: 09355529000026
·
Model: v1.0 (15 vials (0 to 3.2 mM))
·
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FerriScan Phantom
- Primary DI
- 09355529000026
- Version / Model
- v1.0 (15 vials (0 to 3.2 mM))
- Company Name
- RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
- Labeler DUNS
- 740449913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-10
- Public Version
- 3
- Public Version Date
- 2024-04-18
- Public Version Status
- Update
- Public Device Record Key
- c9450f85-25e6-442e-94d4-77a98e802ace
Device Description
Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. It is intended to be used for verification / re-verification of correct MRI scanner sequence configuration for the use of R2-MRI Analysis System (FerriScan)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
| PCS | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox | Radiology | 892.1001 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40636 | MRI phantom, test object | A device that consists of a uniform density, or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions and material densities. It is available in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of magnetic resonance imaging (MRI) systems or magnetic resonance spectroscopy systems and associated image acquisition, display, and analysis computer programs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09355529000026 | GS1 | ||||
| Previous | 09369999026356 | GS1 |
Customer Contacts
- Phone
- +61892865300
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 45 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 45 Degrees Celsius