Model: TD-4116
DI: 00850009854001
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Lancet 100 Pcs
Strip 100 Pcs
Control solution 1 Bottle
Lancing device 1 Pcs
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
379f291b-f844-48fb-ab0d-95ac8355b279
Distribution Status:
In Commercial Distribution
DUNS Number:
117110707
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850009854001
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62645
Name: Glucose analyser IVD, home-use
Definition:
An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; 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. This analyser is typically included in a blood glucose monitoring system.
FDA Product Codes
NBW
System, Test, Blood Glucose, Over The Counter
Premarket Submissions
Submission Number:
K090188
Supplement Number:
000