VentStar Resuscitaire CEU

GUDID 04048675026600

Drägerwerk AG & Co. KGaA

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• Primary Device ID: 04048675026600
• NIH Device Record Key: 4d8d43af-e63b-4fda-b3c2-5c6a388f933f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VentStar Resuscitaire CEU
• Version Model Number: MP00310
• Company DUNS: 315578914
• Company Name: Drägerwerk AG & Co. KGaA
• Device Count: 25
• 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: true
• 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
• 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	04048675026600 [Primary]
GS1	04048675422358 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092029

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

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: 2019-11-27
• Device Publish Date: 2015-10-24

Devices Manufactured by Drägerwerk AG & Co. KGaA

• 04048675436607 - Babyleo TN500: 2024-03-18
• 04048675556169 - Atlan A300 XL: 2023-09-29
• 04048675556176 - Atlan A350: 2023-09-29
• 04048675556183 - Atlan A350 XL: 2023-09-29
• 04048675556343 - Atlan A300: 2023-09-29
• 04048675697718 - SelfTestLung: 2023-09-07
• 04048675389583 - VentStar humidifier chamber (N): 2023-07-31
• 04048675411758 - VentStar Helix heated (N) Plus: 2023-07-31