Accu-Chek Compact Plus

GUDID 00365702701236

Accu-Chek Compact Plus Control L2 (Bio) The UDI information was not placed on the vial label due to the new kit guidance that was published.

Roche Diagnostics Operations, Inc.

Glucose IVD, control

• Primary Device ID: 00365702701236
• NIH Device Record Key: 1ab23cb1-b4ee-41cf-8d9a-9b16d7c7da3c
• Commercial Distribution Discontinuation: 2018-10-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Accu-Chek Compact Plus
• Version Model Number: 06444393001
• Company DUNS: 141608724
• Company Name: Roche Diagnostics Operations, Inc.
• 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: false
• Device Combination Product: false
• Single Use: false
• 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	00365702701236 [Primary]

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

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: 2019-04-29
• Device Publish Date: 2016-08-26

On-Brand Devices [Accu-Chek Compact Plus]

• 00365702701236: Accu-Chek Compact Plus Control L2 (Bio) The UDI information was not placed on the vial label due
• 10365702220109: ACCU-CHEK COMPACT PLUS DME KIT
• 10365702192109: ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS
• 10075537490706: ACCU-CHEK COMPACT PLUS CARE KIT 8/CASE