Device
StatSensor StatStrip Docking Station (Dual Bay)
Manufacturer
NOVA BIOMEDICAL CORPORATION
NOVA BIOMEDICAL CORPORATION
Model: Geen 2.0
Catalog: 66767
DI: 00385480667678
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
StatSensor StatStrip Docking Station (Dual Bay)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
31085e5a-cf27-42ff-b099-ab8010d4f123
Distribution Status:
In Commercial Distribution
DUNS Number:
070617139
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00385480667678
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62538
Name: Glucose monitoring system IVD, point-of-care
Definition:
A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
FDA Product Codes
PZI
Prescription use blood glucose meter for near-patient testing
Premarket Submissions
Submission Number:
K232075
Supplement Number:
000