FDA UDI
In Commercial Distribution
🇺🇸 United States
R2*/T2* Phantom
DI: 09355529000088
·
Model: v1.0
·
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- R2*/T2* Phantom
- Primary DI
- 09355529000088
- Version / Model
- v1.0
- Catalog Number
- -
- 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
- 2024-04-17
- Public Version
- 1
- Public Version Date
- 2024-04-25
- Public Version Status
- New
- Public Device Record Key
- b8352382-be4b-4760-9a08-9dfb48fdc8df
Device Description
The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IXG | Phantom, Anthropomorphic, Radiographic | Radiology | 892.1950 | 1 |
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 | 09355529000088 | GS1 |
Customer Contacts
- Phone
- +61892865300
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 13 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 13 – 40 Degrees Celsius