ACCU-CHEK AVIVA EXPERT 07189486001

GUDID 00365702594104

ACCU-CHEK AVIVA EXPERT DEMO CUSTOMER PK

Roche Diagnostics Operations, Inc.

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: 00365702594104
• NIH Device Record Key: c5837977-06ee-4bd8-a7a4-9b9c9eafd6c8
• Commercial Distribution Discontinuation: 2019-01-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACCU-CHEK AVIVA EXPERT
• Version Model Number: 07189486001
• Catalog Number: 07189486001
• 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: true
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702594104 [Primary]

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: 2019-04-29
• Device Publish Date: 2016-08-26

On-Brand Devices [ACCU-CHEK AVIVA EXPERT]

• 00365702641105: ACCU-CHEK AVIVA EXPERT MG/DL (650)
• 00365702595101: ACCU-CHEK AVIVA EXPERT DEMO KIT
• 00365702594104: ACCU-CHEK AVIVA EXPERT DEMO CUSTOMER PK
• 00365702580107: ACCU-CHEK AVIVA EXPERT CUSTOMER PACK
• 00365702575103: ACCU-CHEK AVIVA EXPERT KIT US