Bacterial/Viral Filter

GUDID 10841470100220

ENGINEERED MEDICAL SYSTEMS INC

Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10841470100220
• NIH Device Record Key: 5a44b976-7a8d-4483-84e2-06ce980a2c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bacterial/Viral Filter
• Version Model Number: 301-435
• Company DUNS: 154502934
• Company Name: ENGINEERED MEDICAL SYSTEMS INC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470100223 [Primary]
GS1	10841470100220 [Package]; Contains: 00841470100223; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013122

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: 2023-12-19
• Device Publish Date: 2023-12-11

Devices Manufactured by ENGINEERED MEDICAL SYSTEMS INC

• 10841470108356 - FENEM: 2023-12-20
• 10841470108370 - FENEM: 2023-12-20
• 10841470109988 - A-PEP: 2023-12-20
• 10841470111196 - DPM: 2023-12-20
• 10841470100220 - Bacterial/Viral Filter: 2023-12-19
• 10841470100220 - Bacterial/Viral Filter: 2023-12-19
• 00841470100230 - Pulmonary Function Filter: 2023-12-19
• 10841470100985 - Aero-Pro: 2023-12-19
• 10841470103436 - Aero-Pro: 2023-12-19