FDA.reportPublic FDA data

Easivent Mask - Small

Primary DI
30349502208011
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
OTC
false
Sterile
false
Single use
false

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, rebreathingA 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.

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
30349502203016Ace Aerosol Cloud Enhancer49502-203-012018-04-10
30349502207014EasiVENT Valved Holding Chamber49502-2072018-04-10

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