FDA.reportPublic FDA data

Easivent Mask - Small

Primary DI
00349502208010
Brand
Easivent Mask - Small
Company
Mylan Specialty L.P.
Model
49502-208-01
Device description
The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece.
Published
2018-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981167000STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KITDhd Healthcare Corp.1998-06-18CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30349502208011PackageGS110In Commercial Distribution
00349502208010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3034950220801130349502208011
00349502208010003495022080103495022080100349502208010

GMDN Terms#

Term, Definition table
TermDefinition
Aerosol face mask, rebreathing, single-useA flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use 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
00349502207013EasiVENT Valved Holding Chamber49502-2072018-04-10
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

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