FDA UDI In Commercial Distribution 🇺🇸 United States

SmartVest

DI: B102060145S0200 · Model: SW-15/25-1 · ELECTROMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SmartVest
Primary DI
B102060145S0200
Version / Model
SW-15/25-1
Catalog Number
SW-15/25-1
Company Name
ELECTROMED, INC.
Labeler DUNS
036514250
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
3
Public Version Date
2019-12-11
Public Version Status
Update
Public Device Record Key
3eb17edb-357b-41cc-888b-76cbb43f3390

Device Description

SPU SmartVest Wrap® – S-Small

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
No
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 B102060145S0200