SmartVest

Basic Information

• Brand Name: SmartVest
• Primary DI: B102070107S0100
• Version / Model: SV-MAINT-KIT
• Catalog Number: SV-MAINT-KIT
• Company Name: ELECTROMED, INC.
• Labeler DUNS: 036514250
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: 2ffbcad4-a1e5-4fc5-bd19-332cfb22aa3b

Device Description

SV2100 Filter & Fuse Maintenance Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYI	Percussor, Powered-Electric	Anesthesiology	868.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38122	Chest-oscillation airway secretion-clearing system vest	A tightly-fitting garment-like device that is a component of a high frequency chest wall oscillation airway secretion-clearing system and which is designed to be worn by a patient to encompass the thorax during high frequency chest wall oscillation (HFCWO) treatment. It is connected via a dedicated thick-walled hose to the system's generator which rapidly inflates and deflates the vest against the chest wall to promote airway clearance by creating HFCWO resulting in the mobilization of bronchial secretions. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B102070107S0100	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K053248	000