SmartVest SV2100-CAN-I

GUDID B102070137S1240

Supplement Kit (Canada – Institutional)

ELECTROMED, INC.

Chest-oscillation airway secretion-clearing system vest

• Primary Device ID: B102070137S1240
• NIH Device Record Key: c9bb5234-41aa-477d-bab3-257c6e2db5c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartVest
• Version Model Number: SV2100-CAN-I
• Catalog Number: SV2100-CAN-I
• Company DUNS: 036514250
• Company Name: ELECTROMED, 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: false
• Lot Batch: false
• 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
HIBCC	B102070137S1240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053248

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: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-03-29

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