Identity
- Trade Name
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE FDA UDI
- Generic Name
- Xenon administration system, diagnostic nuclear medicine FDA UDI
- Device Name
- XENON CIRCUIT FDA UDI
- Model / Reference
- 20125 FDA UDI
- Description
- XENON CIRCUIT FDA UDI
Identifiers
- Catalog Number
- 20125 FDA UDI
- Primary DI / UDI-DI
- 00612649185347 FDA UDI
- 510(k) Number
- K953513 FDA UDI
- FDA Product Code
- IYT FDA UDI
- GMDN Term
- Xenon administration system, diagnostic nuclear medicine FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Xenon administration system, diagnostic nuclear medicine
Disposable Xenon Circuitfor Nuclear Medicine by King Systems Corporation. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K953513 also covers:
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
- DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE — KING SYSTEMS CORPORATION.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- King Systems Corporation.
Sources (1)
- FDA UDI 494de883-d438-4cb1-a648-8d1a08387ffa 37 fields · synced Jun 6, 2026