Resp-O2 Filter

GUDID 00840117305878

Resp-O2 Advantage Filter- Universal Respiratory B/V Filter; Adult/Ped

DYNAREX CORPORATION

Heat/moisture exchanger insertable filter

• Primary Device ID: 00840117305878
• NIH Device Record Key: 8a8dcfa1-ad6e-4e67-97d2-800ff3e84518
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Filter
• Version Model Number: 30400
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117305861 [Primary]
GS1	00840117305878 [Package]; Contains: 00840117305861; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192713

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: 2021-04-30
• Device Publish Date: 2021-04-22

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