Accu-Chek Softclix 09917764001

GUDID 10365702702827

Accu-Chek Softclix Kit Canada

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable

• Primary Device ID: 10365702702827
• NIH Device Record Key: 7b10ca07-feee-4a03-894c-5e84e3e507d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Softclix
• Version Model Number: 09917764001
• Catalog Number: 09917764001
• 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: true
• 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	00365702702820 [Primary]
GS1	10365702702827 [Package]; Contains: 00365702702820; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-30
• Device Publish Date: 2023-03-22

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• 00365702700123: Accu-Chek Softclix AST Kit USA
• 00365702400108: Accu-Chek Softclix (black) USA 12/case
• 00365702156104: Accu-Chek Softclix HN Lancets 100ct 12cs
• 00075537009710: Accu-Chek Softclix Lancets 100ct 12/cs
• 10365702702827: Accu-Chek Softclix Kit Canada