Mask ClassicStar,NIV,SE,L

GUDID 04048675041139

Drägerwerk AG & Co. KGaA

Rebreathing oxygen face mask

• Primary Device ID: 04048675041139
• NIH Device Record Key: 55d1d562-6117-4968-88fe-7e9d178f486c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mask ClassicStar,NIV,SE,L
• Version Model Number: MP01575
• Company DUNS: 315578914
• Company Name: Drägerwerk AG & Co. KGaA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +494518820
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675041139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081743

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

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