FDA UDI
In Commercial Distribution
🇺🇸 United States
XENOVIEW Dose Delivery Bag
DI: 00850045949013
·
Model: Rev B
·
Polarean, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XENOVIEW Dose Delivery Bag
- Primary DI
- 00850045949013
- Version / Model
- Rev B
- Catalog Number
- 44639-01
- 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
- 71162bfb-7245-4220-a8ea-a385a0c85cae
Device Description
The XENOVIEW™ Dose Delivery Bag is used to collect the dispensed XENOVIEW™ (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a clamp to secure XENOVIEW™ inside, and a mouthpiece for the patient to inhale the gas. XENOVIEW™ Dose Delivery Bags come packaged with 50 one-liter dose delivery bag assemblies, as well as 55 individual bag labels. The XENOVIEW™ Dose Delivery Bag is a single-dose disposable drug container, for use with the HPX Hyperpolarization System.
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 66746 | Lung MRI xenon hyperpolarization system delivery bag/mouthpiece | A synthetic polymer reservoir sac with an attached mouthpiece intended to temporarily store hyperpolarized Xenon (Xe) for subsequent patient inhalation to improve lung magnetic resonance imaging (MRI). A lung MRI xenon hyperpolarization system is used to accurately fill a known amount of hyperpolarized Xe into the bag, which is subsequently transported to the patient in the MRI suite for inhalation using the attached mouthpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850045949013 | GS1 |