Aerobika,OPEP

GUDID 50604351505129

AEROBIKA, OPEP DEVICE, RETAIL- 50512

Monaghan Medical Corporation

Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device
Primary Device ID50604351505129
NIH Device Record Keyad30c5a3-4198-4620-915a-9ea672d5f1a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerobika,OPEP
Version Model NumberAerobika, OPEP Device, Retail
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 Kitfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100604351505124 [Primary]
GS150604351505129 [Package]
Contains: 00604351505124
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BWFSpirometer, Therapeutic (Incentive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-24
Device Publish Date2024-05-16

Devices Manufactured by Monaghan Medical Corporation

50604351505129 - Aerobika,OPEP 2024-05-24AEROBIKA, OPEP DEVICE, RETAIL- 50512
50604351505129 - Aerobika,OPEP 2024-05-24 AEROBIKA, OPEP DEVICE, RETAIL- 50512
50604351504122 - Aerochamber Plus® Flow-Vu®2024-03-11 AC Plus, Flow-Vu aVHC, Intermediate Mask, Retail - 50412
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*2023-09-14 AE II BAN with EZ Twist Tubing & Filtered Mouthpiece Kit, cs/25
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