FDA UDI
In Commercial Distribution
🇺🇸 United States
Xenon Master Administration Set
DI: 00850022357664
·
Model: MN5045-IP
·
Medi/Nuclear Corporation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Xenon Master Administration Set
- Primary DI
- 00850022357664
- Version / Model
- MN5045-IP
- Company Name
- Medi/Nuclear Corporation, Inc.
- Labeler DUNS
- 079628327
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-18
- Public Version
- 1
- Public Version Date
- 2022-04-26
- Public Version Status
- New
- Public Device Record Key
- 41cc3450-54fc-40ce-afde-b4f3e55df1aa
Device Description
Air Cushion Face Mask with Injection Port.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | Radiology | 892.1390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40907 | Xenon administration system, diagnostic x-ray/CT | An assembly of devices which is a component of an x-ray/CT (computed tomography) system used in diagnostic x-ray applications for the delivery (by inhalation or injection) of xenon gas during real-time imaging studies of blood flow or other physical or physiological parameters. It can be a simple canister system with associated tubing, mask or mouthpiece, or be composed of an electrically or software-controlled operator's console that includes, e.g., software, injector system, physiological gating devices, gas canister holder(s), gas mixers, tubing sets, gas traps, filters, alarms, mask or mouthpieces. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850022357671 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00850022357664 | GS1 |
Customer Contacts
- Phone
- 800-321-5981
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature