SD GlucoNavii Blood Glucose Test Strip

GUDID 0887473000115

SD Biosensor, Inc.

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

• Primary Device ID: 0887473000115
• NIH Device Record Key: 1ea52573-898a-4753-b05b-a39b2a2994f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SD GlucoNavii Blood Glucose Test Strip
• Version Model Number: 01GS11C
• Company DUNS: 557812789
• Company Name: SD Biosensor, Inc.
• Device Count: 50
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887473000122 [Primary]
GS1	00887473000177 [Unit of Use]
GS1	0887473000115 [Package]; Contains: 00887473000122; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100398

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-23

On-Brand Devices [SD GlucoNavii Blood Glucose Test Strip]

• 00887473000160: 01GS11
• 0887473000115: 01GS11C