Accu-Chek Ultraflex

Basic Information

• Brand Name: Accu-Chek Ultraflex
• Primary DI: 04015630888658
• Version / Model: 06594000001
• Catalog Number: 06594000001
• Company Name: Roche Diabetes Care GmbH
• Labeler DUNS: 313212471
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 5
• Public Version Date: 2021-01-15
• Public Version Status: Update
• Public Device Record Key: bdb42ac6-78ba-49de-809f-5a6e2b188d5f
• Distribution End Date: 2021-01-14

Device Description

Accu-Chek Ultraflex pack of two 6/60 2pc

Device Characteristics

• Single Use: Yes
• 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630888658	GS1
Unit of Use	54015630888653	GS1

Premarket Submissions

Submission Number	Supplement Number
K122686	000