Glucose Pilot 10001

GUDID 00748349000717

Glucose Pilot - The Complete Glucose Monitoring System

SYNTRON BIORESEARCH, INC.

Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00748349000717
• NIH Device Record Key: a10c9506-0061-436e-8bf2-53b3b69a52d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucose Pilot
• Version Model Number: 10001
• Catalog Number: 10001
• Company DUNS: 174517060
• Company Name: SYNTRON BIORESEARCH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00748349000717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052208

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-19
• Device Publish Date: 2020-08-11

Devices Manufactured by SYNTRON BIORESEARCH, INC.

• 00748349000724 - QuikScreen 7+4: 2020-10-06 QuikScreen 7+4 AMP 500, COC 150, MDMA 500, MET 500, OPI 2000, OXY 100, THC50 + PH/CRE/SG/NBP Cat. 65732-7
• 00748349000717 - Glucose Pilot: 2020-08-19Glucose Pilot - The Complete Glucose Monitoring System
• 00748349000717 - Glucose Pilot: 2020-08-19 Glucose Pilot - The Complete Glucose Monitoring System
• 10748349000707 - Be Sure: 2020-07-27 Menopause Test - 1 Test
• 20748349000018 - QuikScreen 11+3 Drug Cup Test: 2018-07-06 QuikScreen 11+3: AMP 1000, BAR 300, BUP 10, BZD 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, THC 50 + adulterant
• 30748349000022 - ForSure iFOB Test Set: 2018-07-06 ForSure iFOB test set Contains: 1 test device 1 test reagent buffer 1 sample collection set (may or may not be included)
• 20748349000049 - QuikSreen 11 Drug Cup Test: 2018-07-06 QuikSreen 11 Drug Cup Test: AMP1000, BAR300, BUP10, BZD300, COC300, MAD300, MDMA500, MET1000, OPI300, OXY100, THC50
• 20748349000056 - QuikScreen 5 Drug Cup Test: 2018-07-06 QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50
• 10748349000066 - QuikStrip MultiDrug 4 Dip Card Test: 2018-07-06 QuikStrip MultiDrug 4 Dip Card: MAD300, OXY 300, OPI300, BZD200