ACCU-CHEK AVIVA PLUS

Basic Information

• Brand Name: ACCU-CHEK AVIVA PLUS
• Primary DI: 00365702134102
• Version / Model: 07021941001
• Catalog Number: 07021941001
• Company Name: Roche Diagnostics Operations, Inc.
• Labeler DUNS: 141608724
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 4
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: 19208562-8420-4c94-a19b-04264a5c9e91
• Distribution End Date: 2022-10-04

Device Description

ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53301	Glucose IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00365702134102	GS1
Package	10365702134109	GS1		8	Not in Commercial Distribution	2022-10-04