FREQUENCER DYMV2.3

GUDID B401DYMV230

The FREQUENCER provides airway clearance therapy and promotes bronchial drainage vibration in chest walls. The device is intended to be a component o

Dymedso Inc

Chest-percussion airway secretion-clearing system

• Primary Device ID: B401DYMV230
• NIH Device Record Key: 454a5227-233f-4edf-999d-07627762c048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREQUENCER
• Version Model Number: V2.3
• Catalog Number: DYMV2.3
• Company DUNS: 243498438
• Company Name: Dymedso Inc
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B401DYMV230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103176

FDA Product Code

• BYI: Percussor, Powered-Electric

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: 2018-03-29
• Device Publish Date: 2017-01-25

On-Brand Devices [FREQUENCER]

• B402DYMV23: The FREQUENCER provides airway clearance therapy and promotes bronchial drainage vibration in ch
• B401DYMV2X0: The Frequencer provides airway clearance therapy and promotes bronchial drainage vibration in th
• B401DYMV230: The FREQUENCER provides airway clearance therapy and promotes bronchial drainage vibration in ch