Prodigy No Coding Blood Glucose Test Strips 75050

GUDID 00384841732000

Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.

PRODIGY DIABETES CARE, LLC

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• Primary Device ID: 00384841732000
• NIH Device Record Key: d353cb4d-bf1c-4a9b-940d-f9c0462fd87b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy No Coding Blood Glucose Test Strips
• Version Model Number: 75050
• Catalog Number: 75050
• Company DUNS: 832875905
• Company Name: PRODIGY DIABETES CARE, LLC
• 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: true
• Lot Batch: true
• Serial Number: true
• 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: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com
• Phone: 1.800.243.2636
• Email: customercare@prodigymeter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384840750500 [Primary]
GS1	00384841732000 [Direct Marking]
NDC/NHRIC	08484-0750-50 [Secondary]
GS1	30384840750501 [Package]; Contains: 00384840750500; Package: Corrugated Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073118

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: 2019-02-18
• Device Publish Date: 2019-01-16

On-Brand Devices [Prodigy No Coding Blood Glucose Test Strips]

• 00384840753006: 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
• 00384841732000: Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
• 00384844732007: 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
• 00384844725009: 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
• 00384844528259: 1 Box of Prodigy No Coding Blood Glucose Test Strips (25 ct).
• 00384840528109: 1 Vial of Prodigy No Coding Blood Glucose Test Strips (10 ct).
• 00384840528000: 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).