Bact-HME 1/2 Basic 6000H

GUDID 30734000672318

HME Filter

Pharma Systems Ps AB

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 30734000672318
• NIH Device Record Key: 9a5ff38d-11cb-4495-b35c-017e3628b612
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bact-HME 1/2 Basic
• Version Model Number: 6000H
• Catalog Number: 6000H
• Company DUNS: 356335752
• Company Name: Pharma Systems Ps AB
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se
• Phone: +4618349500
• Email: info@pharmasys.se

Device Dimensions

• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter
• Length: 8.6 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	30734000672318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202459

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: 2023-11-01
• Device Publish Date: 2023-10-24

Devices Manufactured by Pharma Systems Ps AB

• 30734000671007 - Bact-HME Basic: 2023-11-01 HME Filter
• 30734000671076 - Bact-HME Port: 2023-11-01 HME Filter
• 30734000671182 - Pharma Mini Basic: 2023-11-01 HME Filter
• 30734000671243 - Pharma Mini Port: 2023-11-01 HME Filter
• 30734000671267 - Pharma Mini Port Angle: 2023-11-01 HME Filter
• 30734000671434 - Bact-Trap Basic: 2023-11-01 Bacterial/Viral Filter
• 30734000671441 - Bact-Trap Port: 2023-11-01 Bacterial/Viral Filter
• 30734000671540 - Bact-Trap Mini Basic: 2023-11-01 Bacterial/Viral Filter