Home GUDID 10850632007369 Easy Trak II Blood Glucose Meter
Primary DI 10850632007369
Brand Easy Trak II Blood Glucose Meter
Company HOME AIDE DIAGNOSTICS, INC.
Model 1
Device description Blood Glucose Monitor for use with Easy Trak II Testing Strips only
Published 2020-01-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850632007369 Package GS1 80 In Commercial Distribution 00850632007362 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850632007369 10850632007369 00850632007362 00850632007362 850632007362 0850632007362
GMDN Terms# Term, Definition table Term Definition Glucose monitoring system IVD, home-use 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.
Regulatory Flags# DUNS number 783518983 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860015635518 Ultra-Care Disposable Safety Lancets 30G UCSLAN 2026-05-05 00850071765069 Easy Comfort Safety Lancets 30G 100cnt ECSLAN 2026-05-01 00891237001195 Easy Step Blood Glucose Test Strips 50ct T5D2-00 1195 2016-05-03 00891237001423 Easy Trak Blood Glucose Test Strips 25ct 200020049 1423 2016-05-03 00891237001485 Easy Talk Blood Glucose Testing Strips 25ct 8818 1485 2016-05-03 00891237001645 Easy Plus II Blood Glucose Testing Strips 25ct 8818 1645 2016-05-03 00850027494654 "Easy Comfort Syringes 31G 5/16"" 0.3CC" 4654 2024-10-08 00850027494661 "Easy Comfort Syringes 31G 1/2"" 0.3CC" 4661 2024-10-08 00850027494975 Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count 4975 2024-10-08 00850027494982 Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count 4982 2024-10-08 00850027494999 Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count 4999 2024-10-08 00891237001034 Comfort Heal Heating Pad JY6101 1034 2018-02-14 00850027494517 Smart Neb Pediatric Nebulizer SNebPN 2023-11-03 00850632007225 Easy Neb MCN-S600MB 7225 2018-01-26 00850632007553 Pure Air Mini Nebulizer MCN-S600A 2020-03-24 00891237001607 Easy Air Compressor Nebulizer MCN-S600MC 1607 2016-05-01 00850058864082 Easy Comfort 3L Sharps Container {3.17 Quarts} SC3L 2024-06-14 00850027494340 True Comfort Knee Compression Wrap 4340 2024-10-08 00850027494357 Pure Comfort Leg Massager 4357 2024-10-08 00850027494388 Ultra Comfort Body Massager 4388 2024-10-08
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00682607551354 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551361 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551378 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815234 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815241 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815258 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815265 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551385 ON CALL® SURE BLOOD CONTROL SOLUTION Acon Laboratories, Inc. NBW 2026-07-30 00682607551392 ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607551408 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551422 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551439 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551446 ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607551453 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551460 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551477 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607815098 ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607815104 ON CALL® SURE GK BLOOD GLUCOSE & KETONE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607815111 ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607815272 ON CALL® SURE KETONE CONTROL SOLUTION Acon Laboratories, Inc. NBW 2026-07-30 00850078377265 iHealth iHealth Labs Inc. NBW 2026-07-14 00860015091604 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091611 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091628 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091635 KetoBM KETOBM USA LLC NBW 2026-07-14 04719869706904 Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706911 TysonBio AC500 PRO Blood Glucose Test Strips (50T) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706928 Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706942 Tyson Bio AC500 PRO Control Solution (Level 1) (FDA) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706959 Tyson Bio AC500 PRO Control Solution (Level 3) (FDA) TYSON BIORESEARCH INC. NBW 2026-07-13