Accu-Chek Ultraflex 06593976001

GUDID 04015630888627

Accu-Chek Ultraflex I 6/60 10pcs

Roche Diabetes Care GmbH

Electric infusion pump administration set, single-use

• Primary Device ID: 04015630888627
• NIH Device Record Key: f24908f8-50c2-443d-81ae-7288391d8732
• Commercial Distribution Discontinuation: 2021-09-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Accu-Chek Ultraflex
• Version Model Number: 06593976001
• Catalog Number: 06593976001
• Company DUNS: 313212471
• Company Name: Roche Diabetes Care GmbH
• Device Count: 10
• 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	04015630888627 [Primary]
GS1	54015630888622 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122686

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

Ethylene Oxide

[04015630888627]

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 Ultraflex]

• 04015630888658: Accu-Chek Ultraflex pack of two 6/60 2pc
• 04015630888610: Accu-Chek Ultraflex I 6/30 10pcs
• 04015630052431: Accu-Chek Ultraflex pack of two 2pcs
• 04015630888634: Accu-Chek Ultraflex I 6/80 10pcs
• 04015630888627: Accu-Chek Ultraflex I 6/60 10pcs
• 04015630049974: Accu-Chek Ultraflex I 10/110 10pcs
• 04015630049967: Accu-Chek Ultraflex I 10/80 10pcs
• 04015630049950: Accu-Chek Ultraflex I 10/60 10pcs
• 04015630049943: Accu-Chek Ultraflex I 8/110 10pcs
• 04015630049936: Accu-Chek Ultraflex I 8/80 10pcs
• 04015630049929: Accu-Chek Ultraflex I 8/60 10pcs