FDA UDI
In Commercial Distribution
🇺🇸 United States
HPX Hyperpolarizer
DI: 00850045949006
·
Model: Rev E
·
Polarean, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HPX Hyperpolarizer
- Primary DI
- 00850045949006
- Version / Model
- Rev E
- Catalog Number
- 49820
- 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
- 9b32f9a1-aa80-4218-b4a0-f3a3ad7a0fff
Device Description
The HPX Hyperpolarizer is the device used to hyperpolarize the Xenon Xe 129 Gas Blend for the production of XENOVIEW™. It consists of a laser optical pumping system and a cryogenic xenon condenser system. With the use of the HPX Gas Handling Manifold, the Xenon Xe 129 Gas Blend is delivered to the HPX Hyperpolarizer where it undergoes spin exchange optical pumping (SEOP) process, which produces XENOVIEW™.
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 | 00850045949006 | GS1 |