ACCU-CHEK COMPACT PLUS 05907675001

GUDID 10365702192109

ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry

• Primary Device ID: 10365702192109
• NIH Device Record Key: c9a732b6-40cd-4d00-9c38-5aa0a44ffef6
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACCU-CHEK COMPACT PLUS
• Version Model Number: 05907675001
• Catalog Number: 05907675001
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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	00365702192102 [Primary]
GS1	10365702192109 [Package]; Contains: 00365702192102; Package: [16 Units]; Discontinued: 2017-12-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113614

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• 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