SmartVest SV2100_R

GUDID B102070094S0110

REFURBISHED SV2100 SMARTVEST® ACS

ELECTROMED, INC.

Chest-oscillation airway secretion-clearing system vest

• Primary Device ID: B102070094S0110
• NIH Device Record Key: acb5b914-4859-4f0e-9d3a-9afe75816aa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartVest
• Version Model Number: SV2100_R
• Catalog Number: SV2100_R
• 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: true
• 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	B102070094S0110 [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: 2016-06-30

On-Brand Devices [SmartVest]

• B10209488S1510: Refurb SQL® SmartVest®, Wireless (Red)
• B102090740S8400: SQL-W Supplement Kit (USA)
• B102090683S0100: Mobile Pedestal - SQL®
• B102090649S0800: SQL-I Supplement Kit (Hong Kong)
• B102090649S0700: SQL-I Supplement Kit (Mexico)
• B102090649S0600: SQL-I Supplement Kit (Canada)
• B102090649S0500: SQL-I Supplement Kit (Taiwan)
• B102090649S0400: SQL-I Supplement Kit (Germany)
• B102090649S0300: SQL-I Supplement Kit (Italy)
• B102090649S0200: SQL-I Supplement Kit (Spain)
• B102090649S0100: SQL-I Supplement Kit (USA)
• B102090579S0100: SQL® Replacement Filters - 2-Pack
• B102090535S0100: SQL® Filter & Fuse Maintenance Kit
• B102090504S0100: Power Cord - Class II, North America
• B102090499S8400: SQL® Supplement Kit (USA)
• B102090488S1500: SQL® SmartVest® ACS,Wireless (Red)
• B102090488S1410: Refurb SQL® SmartVest®, Wireless (BT BL)
• B102090488S1400: SQL® SmartVest® ACS,Wireless (Bright BL)
• B102090488S1310: Refurb SQL® SmartVest®, Wireless (Blue)
• B102090488S1300: SQL® SmartVest® ACS,Wireless (Blue)
• B102090488S1110: Refurb SQL® SmartVest®, Wireless
• B102090488S1100: SQL® SmartVest® ACS,Wireless
• B102090488S0510: Refurbished SQL® SmartVest® ACS (Red)
• B102090488S0500: SQL® SmartVest® ACS (Red)
• B102090488S0410: Refurbished SQL® SmartVest® ACS (BT Blue)
• B102090488S0400: SQL® SmartVest® ACS (Bright Blue)
• B102090488S0310: Refurbished SQL® SmartVest® ACS (Blue)
• B102090488S0300: SQL® SmartVest® ACS (Blue)
• B102090488S0210: Refurbished SQL-I SmartVest® ACS
• B102090488S0200: SQL-I SmartVest® ACS
• B102090488S0110: Refurbished SQL® SmartVest® ACS
• B102090488S0100: SQL® SmartVest® ACS
• B102070716S0100: Power Cord – North America
• B102070686S0100: Mobile Pedestal
• B102070622S0100: Refurbished Mobile Pedestal - SV2100-I
• B102070172S0200: LTU Connecting Hose
• B102070172S0100: SPU Connecting Hose
• B102070170S0100: O-Ring Replacement Kit For Connecting Hose
• B102070137S8400: Supplement Kit (USA – Institutional)
• B102070137S1240: Supplement Kit (Canada – Institutional)
• B102070124S9990: Supplement Kit (Custom International)
• B102070124S8400: Supplement Kit (USA)
• B102070124S7920: Supplement Kit (Turkey)
• B102070124S7840: Supplement Kit (United Arab Emirates)
• B102070124S4840: Supplement Kit (Mexico)
• B102070124S4100: Supplement Kit (Republic of Korea)
• B102070124S3920: Supplement Kit (Japan)
• B102070124S3440: Supplement Kit (Hong Kong))
• B102070124S1580: Supplement Kit (Taiwan)
• B102070124S1240: Supplement Kit (Canada)