FDA UDI In Commercial Distribution 🇺🇸 United States

SmartVest

DI: B102090170S0100 · Model: SMARTVEST-OR · ELECTROMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SmartVest
Primary DI
B102090170S0100
Version / Model
SMARTVEST-OR
Catalog Number
SMARTVEST-OR
Company Name
ELECTROMED, INC.
Labeler DUNS
036514250
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-31
Public Version
1
Public Version Date
2023-08-08
Public Version Status
New
Public Device Record Key
dc778a25-3248-424f-a46c-2e39c83ffda4

Device Description

SmartVest O-Ring kit - Black

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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BYI Percussor, Powered-Electric

GMDN Terms

Code Name
38122 Chest-oscillation airway secretion-clearing system vest

Identifiers

Type ID
Primary B102090170S0100