FDA.reportPublic FDA data

N/A

Primary DI
00850022357220
Brand
N/A
Company
Medi/Nuclear Corporation, Inc.
Model
XE-102V
Device description
Valve Assembly, 3 Way for Xenon/Master Patient Delivery System.
Published
2020-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022357220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022357220008500223572208500223572200850022357220

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

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
00850022357848Xenon MasterMN04092024-09-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946430426185GFAXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-06-01
B448260103XpectFirstar Healthcare Company Limited (Guangzhou)CBP2026-05-13
10889483570562AirLife™AIRLIFECBP2025-03-28
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
0076658801349724M - Tampa Electric Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658802201724M - Salt River Project-21 - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588030111XLP - Toyota - Black - XLPouchCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588049045HSB - BBP - Southern Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658806057625M - First Aid Kit - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658806123824PW - Turtle Top Florida DOT - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588070650EMT Trauma Care - Red Cordovia BagCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658808074136M - Enbridge - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658809053510PC - Rail America Locomotive - PolyCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588090610Emergency Trauma Care Deluxe - Orange Co-Polymer CaseCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588100029Sports Bag - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810093710PW - Head Start - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588107042SB-2 - Head Start - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810957210M - Sempra - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658811012710PC - UP - 380-54620 - LocamotiveCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812001010M - State of South Dakota DOT BBP - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812068310PW - Hawaiian TelecomCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812072018PR - First Aid Complete Kit - Poly RedCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812082916PW - PCI Construction - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588121079FAC-4 - Miller & Long ConcreteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812966275V - UP Facilities - RefillCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813049136M - PacifiCorp - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813058316PW - Los Alamos - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15