Mask NovaStarTS,NIV,w/SE,M

GUDID 04048675253419

Drägerwerk AG & Co. KGaA

Rebreathing oxygen face mask

• Primary Device ID: 04048675253419
• NIH Device Record Key: 58cc2b8c-6cf7-43c1-b689-d769f096501a
• Commercial Distribution Discontinuation: 2026-01-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Mask NovaStarTS,NIV,w/SE,M
• Version Model Number: MP01580
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675040569 [Primary]
GS1	04048675253419 [Package]; Contains: 04048675040569; Package: [3 Units]; Discontinued: 2026-01-15; Not in Commercial Distribution

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: 5
• Public Version Date: 2026-01-16
• Device Publish Date: 2015-10-24

Devices Manufactured by Drägerwerk AG & Co. KGaA

• 04048675253426 - Mask NovaStarTS,NIV,w/SE,L: 2026-01-16
• 04048675253402 - Mask NovaStarTS,NIV,w/SE,S: 2026-01-16
• 04048675253419 - Mask NovaStarTS,NIV,w/SE,M: 2026-01-16
• 04048675253419 - Mask NovaStarTS,NIV,w/SE,M: 2026-01-16
• 04048675379300 - IBP Cable Utah: 2026-01-15
• 04048675557722 - IBP Adapter Cable Dräger 7pin: 2026-01-15
• 04048675379072 - IBP cable Becton Dickinson: 2026-01-14
• 04048675379089 - IBP Cable Abbott, Medex: 2026-01-14
• 04048675379096 - IBP cable Edwards: 2026-01-14