FDA UDI
In Commercial Distribution
🇺🇸 United States
DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE
DI: 00612649186306
·
Model: 24116WP
·
King Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE
- Primary DI
- 00612649186306
- Version / Model
- 24116WP
- Catalog Number
- 24116WP
- Company Name
- King Systems Corporation
- Labeler DUNS
- 009299017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 71fc9eb5-551d-4f4f-bf6a-6cb2c43c393b
Device Description
XENON CIRCUIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IYT | System, rebreathing, radionuclide | Radiology | 892.1390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40908 | Xenon administration system, diagnostic nuclear medicine | An assembly of devices which is considered to be a component of a nuclear medicine (NM) imaging system [e.g., a gamma camera or a single photon emission computed tomography (SPECT)] and is used as a rebreathing device to deliver gas to the patient and contain the exhaled radioactive xenon gas used during real-time imaging studies of lung function, blood flow or other physical or physiological parameters. It is designed to minimize release of radioactive gas into the working environment during imaging procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612649103556 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00612649186306 | GS1 |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953513 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size 1 |