FDA.reportPublic FDA data

Aero/Vent Plus, Aero/Vent Max

Primary DI
00850022357428
Brand
Aero/Vent Plus, Aero/Vent Max
Company
Medi/Nuclear Corporation, Inc.
Model
AV-502A
Device description
Aero/Vent Shield Base, Standoff with Mounting Attachments for Aero/Vent (Plus & Max) Portable Shield, Aluminum Case & Aero/Vent Jr Portable Shield Aluminum Case.
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
IYTSystem, Rebreathing, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYTSystem, Rebreathing, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K865107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K865107000AERO-VENT AEROSOL UNITMedi Nuclear Corp., Inc.1987-10-20IYT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022357428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022357428008500223574288500223574280850022357428

GMDN Terms#

Term, Definition table
TermDefinition
Radioaerosol administration setA collection of devices used to quickly deliver radioaerosol to a patient for ventilatory pulmonary scintigraphy. It is used with an aerosol pump/nebulizer or a compressed air line to generate the radioactive aerosol, and a lead (Pb) protective container to hold the radioactive solution during the inhalation procedure. It typically consists of one or several one-way valves to direct the flow of aerosol to the patient, transport tubing to carry the aerosol to the patient, a mouthpiece, and a bacteria filter to trap any exhaled aerosol. This is a single-use device.

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
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
00850022357848Xenon MasterMedi/Nuclear Corporation, Inc.IYT2024-09-10
00850022357855Xenon MasterMedi/Nuclear Corporation, Inc.IYT2024-09-10
00850022357787Insta/Vent, Insta/Vent Plus, MedicatorMedi/Nuclear Corporation, Inc.IYT2023-12-07
00850022357770Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2023-12-07
10850022357784Insta/Vent, Insta/Vent Plus, MedicatorMedi/Nuclear Corporation, Inc.IYT2023-12-07
00850022357794Xenon MasterMedi/Nuclear Corporation, Inc.IYT2023-12-07
00850022357800Xenon MasterMedi/Nuclear Corporation, Inc.IYT2023-12-07
00879942070125AeroTech I Convenience Kit, Small ParticleMirion Technologies (capintec), Inc.IYT2022-08-09
00879942070101AeroTech I Shield Mirion Technologies (capintec), Inc.IYT2022-08-08
00879942070118AeroTech I Convenience Kit, StandardMirion Technologies (capintec), Inc.IYT2022-08-08
00879942070132AeroTech I Convenience Kit, Venti Pak Mirion Technologies (capintec), Inc.IYT2022-08-08
00879942070149Venti-Scan IV ShieldMirion Technologies (capintec), Inc.IYT2022-08-08
00879942070156Venti-Scan IV Convenience Kit, 24 inch tubingMirion Technologies (capintec), Inc.IYT2022-08-08
00879942070163Venti-Scan IV Convenience Kit, Venti PakMirion Technologies (capintec), Inc.IYT2022-08-08
00879942070170Venti-Scan IV Convenience Kit, 12 inch tubingMirion Technologies (capintec), Inc.IYT2022-08-08
00850022357602Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357664Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357596Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357619Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357626Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357640Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357671Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357688Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357114Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357121Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357138Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357169N/AMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357183Insta/Vent - Lung Ventilation AccessoriesMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357237Xenon MasterMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357244Xenon MasterMedi/Nuclear Corporation, Inc.IYT2020-11-09