GL GoodLife AC11-Strip(foil) 3L-10-16003F

GUDID 00389154000709

GL GoodLife Blood Glucose Test Strip(Content:50 strips and 50 lancet.)

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 00389154000709
• NIH Device Record Key: 264a4d39-50c6-4b86-bc91-c6e4d92461d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GL GoodLife AC11-Strip(foil)
• Version Model Number: 3L-10-16003F
• Catalog Number: 3L-10-16003F
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-555-3453
• Email: sales@gl-diabetes.com
• Phone: 1-800-555-3453
• Email: sales@gl-diabetes.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000693 [Primary]
GS1	00389154000709 [Package]; Contains: 00389154000693; Package: [120 Units]; Discontinued: 2017-01-25; Not 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-20
• Device Publish Date: 2017-01-25

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