FDA.reportPublic FDA data

Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., Insta/Vent

Primary DI
00857863007369
Brand
Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., Insta/Vent
Company
Medi/Nuclear Corporation, Inc.
Model
UV-204
Device description
Universal Mobile Cabinet - Metal. (For Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., and Insta/Vent Lead Shields Table Top). Powder coated steel almond color cabinet includes locking decay leaded area, storage area for supplies, swivel casters with front brakes and rubber bumpers on all corners. Oxygen tank holder is 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

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
00857863007369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857863007369008578630073698578630073690857863007369

GMDN Terms#

Term, Definition table
TermDefinition
Teletherapy radionuclide system table, non-poweredA device that is a component of a teletherapy radionuclide system (commonly known as a cobalt therapy machine) and that is a non-electrical radiotherapy table specifically designed to position and support a patient during therapeutic radiation treatments administered using a radionuclide teletherapy system (e.g., a Cobalt-60 teletherapy system). It has a fixed position table top or mechanical table top positioning and/or table height controls, e.g., pneumatic controls, magnetic locks, cranks and lever mechanisms. It can be a stationary or mobile unit, or incorporated as an integral component of a radionuclide teletherapy system or gantry configuration.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth14Inch
Height26Inch
Weight110Pound
Width19.5Inch

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
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