Accu-Chek Combo 05391512001

GUDID 04015630883479

Accu-Chek Spirit Combo Repl. US/en

Roche Diabetes Care GmbH

Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system

• Primary Device ID: 04015630883479
• NIH Device Record Key: 1f0af788-c5c8-4790-b1be-39f577975e9a
• Commercial Distribution Discontinuation: 2021-09-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Accu-Chek Combo
• Version Model Number: 05391512001
• Catalog Number: 05391512001
• Company DUNS: 313212471
• Company Name: Roche Diabetes Care GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630883479 [Primary]

FDA Product Code

• LZG: Pump, Infusion, Insulin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-20
• Device Publish Date: 2016-08-25

On-Brand Devices [Accu-Chek Combo]

• 04015630881505: Accu-Chek Combo Kit Light mg US/en
• 04015630883479: Accu-Chek Spirit Combo Repl. US/en
• 04015630883806: Accu-Chek Combo Kit mg US/en
• 04015630883691: Accu-Chek Aviva Combo Repl. mg (670)
• 04015630880119: Accu-Chek Spirit Combo