Model: Be Smart
DI: 06225000563858
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-07
Current Version: 2026-05-15
Description
1 blood glucose meter; 1 CR2032 Battery.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fc024812-af4f-4e6e-8106-ccde1fdaa7b7
Distribution Status:
In Commercial Distribution
DUNS Number:
658620117
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
06225000563858
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Carton
Item #2 - Device ID:
16225000563855
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
168
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
06225000563858
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 62537
Name: Glucose monitoring system IVD, home-use
Definition:
A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
FDA Product Codes
NBW
System, Test, Blood Glucose, Over The Counter
Premarket Submissions
Submission Number:
K081796
Supplement Number:
000