VentStar Helix heated (N) Plus

GUDID 04048675411758

Drägerwerk AG & Co. KGaA

Ventilator breathing circuit, single-use

• Primary Device ID: 04048675411758
• NIH Device Record Key: 5a0da3d4-cb8d-46b1-8ea7-06e1af2b76b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VentStar Helix heated (N) Plus
• Version Model Number: MP02608
• 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	04048675411758 [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

• 04048675564553 - T-piece N for NO-A: 2024-10-16
• 04048675564577 - T-piece N for Nebulization: 2024-10-16
• 04048675715252 - Anesth Set Flex 160 (BagCone OD22): 2024-10-16
• 04048675035695 - Hook ring LITESTAR,15mm,conn.: 2024-10-10
• 04048675035701 - Hook ring LITESTAR,22mm,conn.: 2024-10-10
• 04048675246558 - Babytherm 8010 System: 2024-08-23
• 04048675703853 - HME HumidStar 2 Plus Luer-Lock: 2024-07-30
• 04048675540137 - Disposable Handle Polaris, Single: 2024-07-18