Accu-Chek Link Assist

Basic Information

• Brand Name: Accu-Chek Link Assist
• Primary DI: 04015630048601
• Version / Model: 04530039001
• Catalog Number: 04530039001
• 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: 2016-08-12
• Public Version: 3
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: c2b0bcf3-690a-4e9f-b7a7-f66d63f5dda7
• Distribution End Date: 2022-07-26

Device Description

Accu-Chek Link Assist

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: Yes
• 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
KZH	Introducer, Syringe Needle	General Hospital	880.6920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60415	Insulin infusion cannula introducer	A non-sterile, hand-held, mechanical device intended to aid introduction of a cannula/needle subcutaneously into fatty tissue for use with an insulin infusion pump. It typically consists of a small housing that chambers the cannula and a triggered release mechanism for automated insertion of the cannula/needle into tissues. It is intended for use in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630048601	GS1