PRODIGY PRO No Coding Blood Glucose Test Strips 051700

GUDID 30384840517005

PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct) Individually Wrapped Foil Packs for Professional Use

PRODIGY DIABETES CARE, LLC

Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care

• Primary Device ID: 30384840517005
• NIH Device Record Key: 775aadac-ceff-4111-bb88-67b793ef1864
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRODIGY PRO No Coding Blood Glucose Test Strips
• Version Model Number: 051700
• Catalog Number: 051700
• Company DUNS: 832875905
• Company Name: PRODIGY DIABETES CARE, LLC
• Device Count: 50
• DM Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com
• Phone: 1 (800) 243-2636
• Email: info@prodigymeter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384840517004 [Primary]
NDC/NHRIC	08484-0517-00 [Secondary]
GS1	10384840517001 [Unit of Use]
GS1	30384840517005 [Package]; Contains: 00384840517004; Package: Inner Case [15 Units]; In Commercial Distribution
GS1	40384840517002 [Package]; Package: Master Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152599

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2020-09-30
• Device Publish Date: 2020-09-22

Devices Manufactured by PRODIGY DIABETES CARE, LLC

• 30384840517005 - PRODIGY PRO No Coding Blood Glucose Test Strips: 2020-09-30PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct) Individually Wrapped Foil Packs for Professional Use
• 30384840517005 - PRODIGY PRO No Coding Blood Glucose Test Strips: 2020-09-30 PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct) Individually Wrapped Foil Packs for Professional Use
• 00384840517752 - PRODIGY Astro PRO Blood Glucose Monitoring System: 2020-09-30 PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
• 00384841732000 - Prodigy No Coding Blood Glucose Test Strips: 2019-02-18 Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
• 00384840810280 - Prodigy Twist Top Lancets: 2018-09-21 Prodigy Twist Top Lancets 28G (100 ct)
• 00384840823167 - Prodigy Pressure Activated Safety Lancets: 2018-09-21 Prodigy Pressure Activated Safety Lancets 26G (100 ct)
• 30384840823410 - Prodigy Pressure Activated Safety Lancets: 2018-09-21 Prodigy Pressure Activated Safety Lancets 21G (100 ct)
• 00384840832251 - Prodigy Adjustable Depth Lancing Device: 2018-09-21 Prodigy Adjustable Depth Lancing Device
• 30384849903380 - Prodigy Pressure Activated Safety Lancets: 2018-09-21 Prodigy Pressure Activated Safety Lancets 28G (100 ct)