Accu-Chek Compact Plus

Basic Information

• Brand Name: Accu-Chek Compact Plus
• Primary DI: 00075537598849
• Version / Model: 05919967160
• Catalog Number: 05919967160
• Company Name: Roche Diabetes Care GmbH
• Labeler DUNS: 313212471
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 4
• Public Version Date: 2021-01-15
• Public Version Status: Update
• Public Device Record Key: 447db7cd-477f-45c2-b7a9-78f482c7824e
• Distribution End Date: 2021-01-14

Device Description

ACCU-CHEK COMPACT PLUS 102CT RTL STR 24

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00075537598849	GS1
Unit of Use	50075537598844	GS1
Package	10075537598846	GS1		24	Not in Commercial Distribution	2021-01-14

Premarket Submissions

Submission Number	Supplement Number
K113614	000