Accu-Chek Spirit Cartridge 05206073001

GUDID 04015630882908

Accu-Chek Spirit 3.15ml Cart. Sys. 25pc

Roche Diabetes Care GmbH

Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir

• Primary Device ID: 04015630882908
• NIH Device Record Key: fad7911f-a55b-416c-956a-92e1d726fafb
• Commercial Distribution Discontinuation: 2022-05-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Accu-Chek Spirit Cartridge
• Version Model Number: 05206073001
• Catalog Number: 05206073001
• Company DUNS: 313212471
• Company Name: Roche Diabetes Care GmbH
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	04015630882908 [Primary]
GS1	54015630882903 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042887

FDA Product Code

• LZG: Pump, Infusion, Insulin

Sterilization

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

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

[04015630882908]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-07-25
• Device Publish Date: 2016-08-26

On-Brand Devices [Accu-Chek Spirit Cartridge]

• 04015630882908: Accu-Chek Spirit 3.15ml Cart. Sys. 25pc
• 04015630882755: Accu-Chek Spirit 3.15ml Cart. Sys. 5pcs