FDA.reportPublic FDA data

Aero/Vent Plus

Primary DI
00857863007239
Brand
Aero/Vent Plus
Company
Medi/Nuclear Corporation, Inc.
Model
AV-400+S
Device description
Aero/Vent Plus Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, and bacteria filter optional
Published
2017-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
00857863007239PackageGS124In Commercial Distribution
00857863007079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857863007239008578630072398578630072390857863007239
00857863007079008578630070798578630070790857863007079

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079628327
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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