Glucose Tolerance Beverage 10-FP-075

GUDID 20859047006018

Glucose Tolerance Beverage, Fruit Punch, 75 Gram

AZER SCIENTIFIC INCORPORATED

Glucose IVD, reagent

• Primary Device ID: 20859047006018
• NIH Device Record Key: fc93ec57-2647-4316-9bf4-4de7febf36d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucose Tolerance Beverage
• Version Model Number: 10-FP-075
• Catalog Number: 10-FP-075
• Company DUNS: 137459512
• Company Name: AZER SCIENTIFIC INCORPORATED
• Device Count: 24
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859047006014 [Unit of Use]
GS1	20859047006018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042183

FDA Product Code

• MRV: Drink, Glucose Tolerance

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: 2019-01-31
• Device Publish Date: 2018-12-31

On-Brand Devices [Glucose Tolerance Beverage]

• 20859047006100: Glucose Tolerance Beverage, Simply Pure, 100 Gram
• 20859047006094: Glucose Tolerance Beverage, Simply Pure, 50 Gram
• 20859047006087: Glucose Tolerance Beverage, Orange, 100 Gram
• 20859047006070: Glucose Tolerance Beverage, Orange, 75 Gram
• 20859047006063: Glucose Tolerance Beverage, Orange, 50 Gram
• 20859047006056: Glucose Tolerance Beverage, Lemon Lime, 100 Gram
• 20859047006049: Glucose Tolerance Beverage, Lemon Lime, 75 Gram
• 20859047006032: Glucose Tolerance Beverage, Lemon Lime, 50 Gram
• 20859047006025: Glucose Tolerance Beverage, Fruit Punch, 100 Gram
• 20859047006018: Glucose Tolerance Beverage, Fruit Punch, 75 Gram
• 20859047006001: Glucose Tolerance Beverage, Fruit Punch, 50 Gram