Accu-Chek Ultraflex 06594000001

GUDID 04015630888658

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

Roche Diabetes Care GmbH

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use

• Primary Device ID: 04015630888658
• NIH Device Record Key: bdb42ac6-78ba-49de-809f-5a6e2b188d5f
• Commercial Distribution Discontinuation: 2021-01-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Accu-Chek Ultraflex
• Version Model Number: 06594000001
• Catalog Number: 06594000001
• Company DUNS: 313212471
• Company Name: Roche Diabetes Care GmbH
• Device Count: 2
• 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	04015630888658 [Primary]
GS1	54015630888653 [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

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

[04015630888658]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-01-15
• Device Publish Date: 2016-08-26

On-Brand Devices [Accu-Chek Ultraflex]

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• 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