VENTSTAR Carina LeakV

GUDID 04048675422334

Drägerwerk AG & Co. KGaA

Non-rebreathing valve, reusable

• Primary Device ID: 04048675422334
• NIH Device Record Key: 4e847fb4-2486-4820-9b1a-00882a68118d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTSTAR Carina LeakV
• Version Model Number: MP00312
• 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	04048675422334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072885

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: 2022-06-27
• Device Publish Date: 2022-06-17

Devices Manufactured by Drägerwerk AG & Co. KGaA

• 04048675125525 - CLIC adapter: 2025-05-02
• 04048675379317 - ECG trunk cable,3-lead,Neo: 2025-04-18
• 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