ACCU-CHEK AVIVA PLUS 07021941001

GUDID 00365702134102

ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE

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 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 Glucose IVD, kit, spectrophotometry

• Primary Device ID: 00365702134102
• NIH Device Record Key: 19208562-8420-4c94-a19b-04264a5c9e91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCU-CHEK AVIVA PLUS
• Version Model Number: 07021941001
• Catalog Number: 07021941001
• 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	00365702134102 [Primary]
GS1	10365702134109 [Package]; Package: [8 Units]; In Commercial Distribution

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: 2018-03-29
• Device Publish Date: 2016-08-26

On-Brand Devices [ACCU-CHEK AVIVA PLUS ]

• 00365702700932: VIAL LBLD 10CT STRIP AC AVIVA PLUS BRK
• 00365702445109: ACCU-CHEK AVIVA PLUS SAMPLE KIT 16/CASE
• 10365702438108: ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS
• 00365702437104: ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C
• 10365702436104: ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS
• 10365702408101: ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C
• 10365702407104: ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C
• 00365702405103: ACCU-CHEK AVIVA PLUS 10CT STRIP BRK
• 00365702134102: ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE
• 00365702102101: ACCU-CHEK AVIVA PLUS METER-ONLY
• 00365702101104: ACCU-CHEK AVIVA PLUS RETAIL KIT 8/CASE