Accu-Chek Guide Me

GUDID 10365702733104

Accu-Chek Guide Me Smpl Kit FC mg/dl US

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry

• Primary Device ID: 10365702733104
• NIH Device Record Key: f35b70b6-6b2b-45f5-a49d-457b5fbf53fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Guide Me
• Version Model Number: 08499918001
• Company DUNS: 141608724
• Company Name: Roche Diagnostics Operations, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702733107 [Primary]
GS1	10365702733104 [Package]; Contains: 00365702733107; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181131

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: 2
• Public Version Date: 2019-09-30
• Device Publish Date: 2019-04-08

On-Brand Devices [Accu-Chek Guide Me]

• 10365702733104: Accu-Chek Guide Me Smpl Kit FC mg/dl US
• 10365702732107: Accu-Chek Guide Me Meter Only mg/dl US
• 00365702731103: Accu-Chek Guide Me Retail Kit mg/dl US
• 10365702730103: ACCU-CHEK GUIDE ME HNP KIT MG/DL US