ACCU-CHEK Inform II

GUDID 00365702237100

Accu-Chek Inform II controls US 10/CS

Roche Diagnostics Operations, Inc.

Glucose IVD, control

• Primary Device ID: 00365702237100
• NIH Device Record Key: c0459a4e-9669-4226-9fe4-28e49e9b3067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCU-CHEK Inform II
• Version Model Number: 05213509001
• 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: 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	00365702237100 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-26

On-Brand Devices [ACCU-CHEK Inform II]

• 00365702474109: ACCU-CHEK LINEARITY KIT U.S.
• 10365702428109: ACCU-CHEK INFORM II US 50CT 36/CS F2
• 00365702237100: Accu-Chek Inform II controls US 10/CS