FDA.reportPublic FDA data

EasiVENT Valved Holding Chamber

Primary DI
00349502207013
Brand
EasiVENT Valved Holding Chamber
Company
Mylan Specialty L.P.
Model
49502-207
Device description
Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is comprised of a MDI adapter port, Holding chamber, a one way valve, Mouth Piece and mouthpiece cap
Published
2018-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30349502207014PackageGS112In Commercial Distribution
30349502207250PackageGS125In Commercial Distribution
00349502207013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3034950220701430349502207014
3034950220725030349502207250
00349502207013003495022070133495022070130349502207013

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-395-3376customer.service@mylan.com

Regulatory Flags#

DUNS number
194775557
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00349502203015Ace Aerosol Cloud Enhancer49502-203-012018-04-10
00349502208010Easivent Mask - Small49502-208-012018-04-10
00349502208027Easivent Mask - Medium49502-208-022018-04-10
00349502208034Easivent Mask - Large49502-208-032018-04-10
30349502208011Easivent Mask - Small49502-208-012018-04-10
30349502203016Ace Aerosol Cloud Enhancer49502-203-012018-04-10
30349502207014EasiVENT Valved Holding Chamber49502-2072018-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
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