GL GoodLife Blood Glucose Test Strip 3S-01-16003E

GUDID 00389145000600

GL GoodLife Blood Glucose Test Strip(AC-302)

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00389145000600
• NIH Device Record Key: c42b7dcf-89e2-4592-baba-49c88b25536d
• Commercial Distribution Discontinuation: 2016-12-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GL GoodLife Blood Glucose Test Strip
• 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 n
• 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	00389145000600 [Package]; Contains: 00389154000594; Package: [400 Units]; Discontinued: 2016-12-09; Not in Commercial Distribution
GS1	00389154000594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113307

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-09

On-Brand Devices [GL GoodLife Blood Glucose Test Strip]

• 00389145000600: GL GoodLife Blood Glucose Test Strip(AC-302)
• 03891450006004: GL GoodLife Blood Glucose Test Strip(AC-302)