Device
The DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips...
Manufacturer
UAN HEALTHCARE LIMITED
UAN HEALTHCARE LIMITED
Model: DS-W
DI: 00850080988428
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-09
Current Version: 2026-05-18
Description
The DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The DS-W Draw-in Blood Glucose Test Strips are for use with the DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f43b0332-b379-4f78-8a25-738abd94b928
Distribution Status:
In Commercial Distribution
DUNS Number:
765349382
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850080988428
Type:
Primary
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
CGA
Glucose Oxidase, Glucose
QRL
Multiple Use Blood Lancet For Single Patient Use Only
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature