Filter/HME TwinStar HEPA Plus

GUDID 04048675665823

Drägerwerk AG & Co. KGaA

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 04048675665823
• NIH Device Record Key: 87eb955e-382f-425d-82fa-c8a716317fce
• Commercial Distribution Discontinuation: 2025-07-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Filter/HME TwinStar HEPA Plus
• Version Model Number: MP05801
• 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	04048675665823 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-23
• Device Publish Date: 2023-01-09

Devices Manufactured by Drägerwerk AG & Co. KGaA

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• 04048675665762 - Filter SafeStar 90 Plus: 2026-01-23
• 04048675665786 - Filter SafeStar 60A Plus: 2026-01-23
• 04048675665823 - Filter/HME TwinStar HEPA Plus: 2026-01-23
• 04048675665823 - Filter/HME TwinStar HEPA Plus: 2026-01-23
• 04048675253426 - Mask NovaStarTS,NIV,w/SE,L: 2026-01-16
• 04048675253402 - Mask NovaStarTS,NIV,w/SE,S: 2026-01-16
• 04048675253419 - Mask NovaStarTS,NIV,w/SE,M: 2026-01-16
• 04048675379300 - IBP Cable Utah: 2026-01-15