CombiStar Plus Filter + HME HEPA flex

GUDID 04048675714422

Drägerwerk AG & Co. KGaA

Breathing circuit catheter mount, single-use

• Primary Device ID: 04048675714422
• NIH Device Record Key: 9550e7d6-32ee-44ac-8ef9-df9404183a1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CombiStar Plus Filter + HME HEPA flex
• Version Model Number: MP12062
• 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: 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	04048675714422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221836

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2024-10-15
• Device Publish Date: 2024-10-07

Devices Manufactured by Drägerwerk AG & Co. KGaA

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• 04048675686743 - VentStar AutoBreath heated (N): 2025-05-22
• 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