HEPA Filter

GUDID 00709078001567

w/o CO2 Port

WESTMED, INC.

Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile 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: 00709078001567
• NIH Device Record Key: fa259aae-66c3-4630-8c40-874fd0bc9ada
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEPA Filter
• Version Model Number: 6234
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• Device Count: 100
• 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: false
• 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	00709078001567 [Primary]
GS1	00709078002113 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040712

FDA Product Code

• MOD: Accessory To Continuous Ventilator (Respirator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-23

On-Brand Devices [HEPA Filter]

• 10709078002240: *HEPA Filter with Port and Elbow (6224)
• 00709078001567: w/o CO2 Port
• 10709078014007: Hepa Filter W/CO2 port (TwinMed)