Easivent Mask - Large

GUDID 00349502208034

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.

MYLAN SPECIALTY L.P.

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• Primary Device ID: 00349502208034
• NIH Device Record Key: 78e6841f-a2b3-4c17-abfc-aced69598ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easivent Mask - Large
• Version Model Number: 49502-208-03
• Company DUNS: 194775557
• Company Name: MYLAN SPECIALTY L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com
• Phone: 1-800-395-3376
• Email: customer.service@mylan.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00349502208034 [Primary]
GS1	30349502208035 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981167

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-10

Devices Manufactured by MYLAN SPECIALTY L.P.

• 30349502208011 - Easivent Mask - Small: 2018-07-06 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 - Medium: 2018-07-06 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 - Large: 2018-07-06The 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.
• 00349502208034 - Easivent Mask - Large: 2018-07-06 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 Enhancer: 2018-05-11 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 Chamber: 2018-05-11 Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is compri