VentStar Helix dual heated N Exten. Kit

GUDID 04048675742739

Drägerwerk AG & Co. KGaA

Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use 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

• 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