VentStar Helix dual heated N Exten. Kit

GUDID 04048675742739

Drägerwerk AG & Co. KGaA

Ventilator breathing circuit, single-use

• Primary Device ID: 04048675742739
• NIH Device Record Key: 0b654bd9-698f-4585-8929-c9dfe5857316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VentStar Helix dual heated N Exten. Kit
• Version Model Number: MP02280
• Company DUNS: 315578914
• Company Name: Drägerwerk AG & Co. KGaA
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675742739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222822

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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: 2023-07-31
• Device Publish Date: 2023-07-21

Devices Manufactured by Drägerwerk AG & Co. KGaA

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• 04048675379324 - ECG limb wires, 3-lead, IEC: 2025-04-18
• 04048675379331 - ECG limb wires,5-lead,IEC: 2025-04-18
• 04048675379348 - ECG trunk cable,3-lead,IEC/AHA: 2025-04-18
• 04048675379355 - ECG trunk cable,5-lead,IEC/AHA: 2025-04-18
• 04048675379362 - ECG limb wires, 3-lead, AHA: 2025-04-18
• 04048675379379 - ECG Limb Wires, 5-lead, AHA: 2025-04-18