FDA.reportPublic FDA data

EasiVENT Valved Holding Chamber

Primary DI
30349502207014
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
194775557
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00349502203015Ace Aerosol Cloud Enhancer49502-203-012018-04-10
00349502207013EasiVENT Valved Holding Chamber49502-2072018-04-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
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