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

FDA UDI

Class II (US FDA UDI)

by Medi Nuclear Corp., Inc.

Identity

Trade Name
Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., Insta/Vent FDA UDI
Generic Name
Teletherapy radionuclide system table, non-powered FDA UDI
Device Name
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. FDA UDI
Model / Reference
UV-204 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00857863007369 FDA UDI
510(k) Number
K865107 FDA UDI
FDA Product Code
IYT FDA UDI
GMDN Term
Teletherapy radionuclide system table, non-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1390 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 110 Pound FDA UDI
Height — 26 Inch FDA UDI
Depth — 14 Inch FDA UDI
Width — 19.5 Inch FDA UDI

Category: Teletherapy radionuclide system table, non-powered

Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., Insta/Vent by Medi Nuclear Corp., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Teletherapy radionuclide system table, non-powered.

Cleared under the same submission

K865107 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medi Nuclear Corp., Inc.

Sources (1)

  • FDA UDI 2957a19b-e1d1-4f5a-aae6-24e337526951 37 fields · synced Jun 1, 2026