Aero/Vent Plus

GUDID 00857863007239

Aero/Vent Plus Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, and bacteria filter optional

Medi/Nuclear Corporation, Inc.

Radioaerosol administration set
Primary Device ID00857863007239
NIH Device Record Keyde3a832b-4a19-499e-97bb-179e0d09910f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero/Vent Plus
Version Model NumberAV-400+S
Company DUNS079628327
Company NameMedi/Nuclear Corporation, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-321-5981
Emailcs@medinuclear.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100857863007079 [Primary]
GS100857863007239 [Package]
Contains: 00857863007079
Package: Carton [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYTSystem, Rebreathing, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-09

On-Brand Devices [Aero/Vent Plus]

00857863007994Filter, HEPA, Disposable
00857863007918Lead Adapter Replacement, Powder coated lead adapter with 7 ft. oxygen tube with secure fit conn
00857863007680Elbow, 22mm OD x 22mm ID
00857863007673Nose Clip, Disposable with Foam Nose Pads
00857863007550Face Mask, Air-Cushioned, Adult Size 5, 22mm ID w/Adapter
00857863007543Face Mask, Air-Cushioned, Adult Size 5, 22mm ID
00857863007239Aero/Vent Plus Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, and bacteria filter
00857863007246Aero/Vent Plus Ventilator Kit w/HEPA Filter, For ventilator dependent patients
00857863007222Aero/Vent Plus w/HEPA Filter & Mask
00857863007215Aero/Vent Plus Radioaerosol Unit w/HEPA Filter

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.