AeroEclipse* BAN*

GUDID 00604351602250

AE II BAN with EZ Twist Tubing & Filtered Mouthpiece Kit, cs/25

Monaghan Medical Corporation

Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable
Primary Device ID00604351602250
NIH Device Record Key3231ff6a-9b13-4c8f-bee3-d0bf288b1a70
Commercial Distribution StatusIn Commercial Distribution
Brand NameAeroEclipse* BAN*
Version Model NumberAE II BAN & Filtered Mouthpiece, cs/25
Company DUNS056332380
Company NameMonaghan Medical Corporation
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com
Phone518-561-7330
Emailcustomerservice@monaghanmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100604351602250 [Primary]
GS150604351602255 [Package]
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-14
Device Publish Date2023-09-06

Devices Manufactured by Monaghan Medical Corporation

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00604351500129 - Aerochamber Plus® Flow-Vu®2023-11-22 AC+FV aVHC Mouthpiece Retail - 50012
50604351501121 - Aerochamber Plus® Flow-Vu®2023-11-22 AC Plus, Flow-Vu aVHC, Small Mask, Retail - 50112
50604351502128 - Aerochamber Plus® Flow-Vu®2023-11-22 AC Plus, Flow-Vu aVHC, Medium Mask, Retail - 50212
50604351503125 - Aerochamber Plus® Flow-Vu®2023-11-22 AC Plus, Flow-Vu aVHC, Large Mask, Retail - 50312
50604351601258 - AeroEclips*BAN*2023-09-14 AE II BAN with Universal Tubing & Filtered Mouthpiece Kit, cs/25
00604351602250 - AeroEclipse* BAN*2023-09-14AE II BAN with EZ Twist Tubing & Filtered Mouthpiece Kit, cs/25
00604351602250 - AeroEclipse* BAN*2023-09-14 AE II BAN with EZ Twist Tubing & Filtered Mouthpiece Kit, cs/25
50604351600527 - Filtered Mouthpiece2023-09-01
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