GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) 3K-01-16003R

GUDID 00857596008022

GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type.

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00857596008022
• NIH Device Record Key: 86ac89bc-2150-4202-8b8d-6d96f4227671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.)
• Version Model Number: AC-11 AC302
• Catalog Number: 3K-01-16003R
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00857596008022 [Primary]
GS1	00857596008039 [Package]; Package: [60 Units]; In Commercial Distribution

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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