FDA UDI
In Commercial Distribution
🇺🇸 United States
HPX Polarization Measurement Station
DI: 00850045949020
·
Model: Rev. D
·
Polarean, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HPX Polarization Measurement Station
- Primary DI
- 00850045949020
- Version / Model
- Rev. D
- Catalog Number
- 42881
- Company Name
- Polarean, Inc.
- Labeler DUNS
- 078629330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-04
- Public Version
- 1
- Public Version Date
- 2023-05-12
- Public Version Status
- New
- Public Device Record Key
- 861eabf8-e373-49a3-a0e7-eda0d2f94c11
Device Description
The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 129 signal. The HPX Polarization Measurement Station accomplishes the following: Ensures that the amount of XENOVIEW™ in the XENOVIEW™ Dose Delivery Bag is sufficient for measurement; Calculates the Dose Equivalent (DE) value prior to administration to a patient; Stores a XENOVIEW™ Dose Delivery Bag filled with XENOVIEW™ in a static magnetic field.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| QVW | Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66745 | Lung MRI xenon hyperpolarization system | An electrically-powered assembly of devices designed for the production and measurement of hyperpolarized xenon (Xe) gas delivered to the lungs to improve lung magnetic resonance imaging (MRI) during assessment of lung function. It consists of a hyperpolarized xenon generator, a measurement station, and gas delivery equipment. The system includes a wide variety of technologies such as laser-based hyperpolarization, magnetic field generation to slow relaxation of hyperpolarized Xe, and nuclear magnetic resonance (NMR) based measurement of hyperpolarized Xe; it is used with a disposable delivery bag for measured dosing of hyperpolarized Xe to the patient via a mask/mouthpiece. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850045949020 | GS1 |