Accu-Chek Combo

Basic Information

• Brand Name: Accu-Chek Combo
• Primary DI: 04015630880119
• Version / Model: 05027250001
• Company Name: Roche Diabetes Care GmbH
• Labeler DUNS: 313212471
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 3
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: 4a328b24-223c-411b-93cd-9047ff15b125
• Distribution End Date: 2022-05-01

Device Description

Accu-Chek Spirit Combo

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZG	Pump, Infusion, Insulin	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51083	Ambulatory insulin infusion pump/blood glucose analyser system	An assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630880119	GS1