Accu-Chek Care 10095946001

GUDID 04015630088928

Accu-Chek Care (HCP)

Roche Diabetes Care GmbH

Medical equipment clinical data interfacing software

• Primary Device ID: 04015630088928
• NIH Device Record Key: 0348370b-1a5e-46cb-9cda-dedc9e2a84c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Care
• Version Model Number: 10095946001
• Catalog Number: 10095946001
• Company DUNS: 313212471
• Company Name: Roche Diabetes Care GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630088928 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-15
• Device Publish Date: 2024-11-07

Devices Manufactured by Roche Diabetes Care GmbH

• 04015630088928 - Accu-Chek Care: 2024-11-15Accu-Chek Care (HCP)
• 04015630088928 - Accu-Chek Care: 2024-11-15 Accu-Chek Care (HCP)
• 04015630046713 - Accu-Chek Rapid-D: 2023-07-25 Accu-Chek Rapid-D 6/80 15+5+5pcs
• 04015630048601 - Accu-Chek Link Assist: 2023-07-25 Accu-Chek Link Assist
• 04015630049929 - Accu-Chek Ultraflex: 2023-07-25 Accu-Chek Ultraflex I 8/60 10pcs
• 04015630049936 - Accu-Chek Ultraflex: 2023-07-25 Accu-Chek Ultraflex I 8/80 10pcs
• 04015630049943 - Accu-Chek Ultraflex: 2023-07-25 Accu-Chek Ultraflex I 8/110 10pcs
• 04015630049950 - Accu-Chek Ultraflex: 2023-07-25 Accu-Chek Ultraflex I 10/60 10pcs
• 04015630049967 - Accu-Chek Ultraflex: 2023-07-25 Accu-Chek Ultraflex I 10/80 10pcs