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Xenon Master

FDA UDI

Class II (US FDA UDI)

by Medi Nuclear Corp., Inc.

Identity

Trade Name
Xenon Master FDA UDI
Generic Name
Xenon administration system, diagnostic x-ray/CT FDA UDI
Device Name
Xenon/Master Patient Delivery System. (For Xenon Gas Delivery). Mobile Cabinet type constructed of wood and almond color formica with leaded areas for Xenon Delivery. Includes one charcoal activated trap and has extra space for one additional activated trap (optional) for high use facilities, swivel casters with front brakes. Xenon accessory samples included. FDA UDI
Model / Reference
XE-102 FDA UDI
Description
Xenon/Master Patient Delivery System. (For Xenon Gas Delivery). Mobile Cabinet type constructed of wood and almond color formica with leaded areas for Xenon Delivery. Includes one charcoal activated trap and has extra space for one additional activated trap (optional) for high use facilities, swivel casters with front brakes. Xenon accessory samples included. FDA UDI

Identifiers

Primary DI / UDI-DI
00857863007390 FDA UDI
510(k) Number
K810819 FDA UDI
FDA Product Code
IYT FDA UDI
GMDN Term
Xenon administration system, diagnostic x-ray/CT 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 200 Pound FDA UDI
Height — 42 Inch FDA UDI
Length — 18 Inch FDA UDI
Width — 18 Inch FDA UDI

Category: Xenon administration system, diagnostic x-ray/CT

Xenon Master by Medi Nuclear Corp., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Xenon administration system, diagnostic x-ray/CT.

Cleared under the same submission

K810819 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medi Nuclear Corp., Inc.

Sources (1)

  • FDA UDI 08f0a865-788a-4fba-89fe-b368461e852a 37 fields · synced May 30, 2026