Accu-Chek Guide Me

GUDID 00365702731103

Accu-Chek Guide Me Retail Kit mg/dl US

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry

• Primary Device ID: 00365702731103
• NIH Device Record Key: 394cbbfe-daa5-4a37-8c79-c99440742d38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Guide Me
• Version Model Number: 08499896001
• 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	00365702731103 [Primary]
GS1	10365702731100 [Package]; Package: [10 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