Babylog VN600

GUDID 04048675551713

Drägerwerk AG & Co. KGaA

Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator Neonatal intensive-care ventilator

• Primary Device ID: 04048675551713
• NIH Device Record Key: 280ca7ca-e6a6-4794-89ad-03ce4d14da87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babylog VN600
• Version Model Number: 8422200
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675551713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222207

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-12
• Device Publish Date: 2023-06-02

Devices Manufactured by Drägerwerk AG & Co. KGaA

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• 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