Ace Aerosol Cloud Enhancer

GUDID 30349502203016

The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery.

MYLAN SPECIALTY L.P.

Atomizer
Primary Device ID30349502203016
NIH Device Record Keya926b9b6-3690-426b-88f7-cf9723305146
Commercial Distribution StatusIn Commercial Distribution
Brand NameAce Aerosol Cloud Enhancer
Version Model Number49502-203-01
Company DUNS194775557
Company NameMYLAN SPECIALTY L.P.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com
Phone1-800-395-3376
Emailcustomer.service@mylan.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100349502203015 [Primary]
GS130349502203016 [Package]
Contains: 00349502203015
Package: Case [12 Units]
In Commercial Distribution

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 Date2018-05-11
Device Publish Date2018-04-10

Devices Manufactured by MYLAN SPECIALTY L.P.

30349502208011 - Easivent Mask - Small2018-07-06 The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask
00349502208027 - Easivent Mask - Medium2018-07-06 The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask
00349502208034 - Easivent Mask - Large2018-07-06 The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask
30349502203016 - Ace Aerosol Cloud Enhancer2018-05-11The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery.
30349502203016 - Ace Aerosol Cloud Enhancer2018-05-11 The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotrach
30349502207014 - EasiVENT Valved Holding Chamber2018-05-11 Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is compri

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