GL GoodLife Blood Glucose Test Strip(CORP.) 3S-01-16003E

GUDID 00857596008046

GL GoodLife Blood Glucose Test Strip(AC-302)

HMD BIOMEDICAL INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 00857596008046
• NIH Device Record Key: 018f70f7-8c21-464d-aef8-d5d25a5830e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GL GoodLife Blood Glucose Test Strip(CORP.)
• Version Model Number: AC-11 AC302 (vial)
• Catalog Number: 3S-01-16003E
• Company DUNS: 658644174
• Company Name: HMD BIOMEDICAL 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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	00857596008046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113307

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: 2019-02-08
• Device Publish Date: 2019-01-08

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