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Disposable Xenon Circuitfor Nuclear Medicine

FDA UDI

Class II (US FDA UDI)

by King Systems Corporation.

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
22116 FDA UDI
Description
XENON CIRCUIT FDA UDI

Identifiers

Catalog Number
22116 FDA UDI
Primary DI / UDI-DI
00612649186122 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
Not 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

Disposable Xenon Circuitfor Nuclear Medicine by King Systems Corporation. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K953513 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
King Systems Corporation.

Sources (1)

  • FDA UDI d6baef69-1b75-4458-bda3-50470187854e 38 fields · synced Jun 1, 2026