FDA.reportPublic FDA data

Xenon Master

Primary DI
00850022357848
Brand
Xenon Master
Company
Medi/Nuclear Corporation, Inc.
Model
MN0409
Device description
Xenon Administration Set: 1 EA MN0309: Face Mask, Air-Cushioned, Adult Size 5, with Injection Port & Bacteria Filter, Flexible Tubing.1 EA MN2772: Moisture Absorbing Granule Cartridge, Disposable,(Drierite). 1 EA MN2773: C02 Absorbing Granule Cartridge, Disposable, (Soda Lime).
Published
2024-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBLAbsorbent, Carbon-Dioxide
IYTSystem, Rebreathing, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBLAbsorbent, Carbon-DioxideAnesthesiology1
IYTSystem, Rebreathing, RadionuclideRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022357848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022357848008500223578488500223578480850022357848

GMDN Terms#

Term, Definition table
TermDefinition
Xenon administration system, diagnostic x-ray/CTAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-321-5981cs@medinuclear.com

Regulatory Flags#

DUNS number
079628327
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022357817Xenon MasterMN00282024-09-10
00850022357824Xenon MasterMN00382024-09-10
00850022357831Xenon MasterMN00402024-09-10
00850022357855Xenon MasterMN04122024-09-10
00850022357176N/AMN00392020-11-09
00850022357152N/AMN00022020-11-09
00857863007468Aero/Vent PlusMN50452017-06-09
00857863007475Aero/Vent PlusMN71102017-06-09
00850022357787Insta/Vent, Insta/Vent Plus, MedicatorMN12132023-12-07
00850022357770Xenon Master Administration SetMN2892M2023-12-07
10850022357784Insta/Vent, Insta/Vent Plus, MedicatorMN12132023-12-07
00850022357794Xenon MasterMN27722023-12-07
00850022357800Xenon MasterMN27732023-12-07
00850022357701Insta/Vent - Safe-T-Shield MouthpieceMNMP500-NC2022-04-18
00857863007857N/AMN2550B2017-06-09
00857863007864SAFE-T-SHIELD MouthpieceMNMP5002017-06-09
00850022357114Xenon Master Administration SetMN60012020-11-09
00850022357121Xenon Master Administration SetMN27002020-11-09
00850022357138Xenon Master Administration SetMN2891M2020-11-09
00850022357183Insta/Vent - Lung Ventilation AccessoriesMN03052020-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008449870SpiraLith CaMicropore, Inc.CBL2025-05-28
10860008449877SpiraLith CaMicropore, Inc.CBL2025-05-28
10889483583364Medisorb™AirLife Finland OyCBL2025-04-22
10889483589922Medisorb™AirLife Finland OyCBL2025-04-22
10889483590522Medisorb™AirLife Finland OyCBL2025-04-22
20889483583361Medisorb™AirLife Finland OyCBL2025-04-22
20889483589929Medisorb™AirLife Finland OyCBL2025-04-22
20889483590529Medisorb™AirLife Finland OyCBL2025-04-22
10889483577417Medisorb™AirLife Finland OyCBL2025-04-09
10889483577424Medisorb™AirLife Finland OyCBL2025-04-09
20889483577414Medisorb™AirLife Finland OyCBL2025-04-09
20889483577421Medisorb™AirLife Finland OyCBL2025-04-09
10889483573488Medisorb™AirLife Finland OyCBL2025-04-07
10889483603468Medisorb™AirLife Finland OyCBL2025-04-01
10889483603475Medisorb™AirLife Finland OyCBL2025-04-01
20889483603465Medisorb™AirLife Finland OyCBL2025-04-01
20889483603472Medisorb™AirLife Finland OyCBL2025-04-01
10193489081633MEDLINEMEDLINE INDUSTRIES, INC.CBL2024-10-25
20193489081630MEDLINEMEDLINE INDUSTRIES, INC.CBL2024-10-25
00850022357817Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357824Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357831Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357855Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357855Xenon MasterMedi/Nuclear Corporation, Inc.IYT2024-09-10
07898592088819AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088833AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088888AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088901AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088956AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088970AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26