Accu-Chek Coaguchek Softclix 08015333001

GUDID 00365702702240

CoaguChek Softclix Lancets USA 10ct

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable

• Primary Device ID: 00365702702240
• NIH Device Record Key: 8875b091-62ff-4737-8e68-cee81faeff6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Coaguchek Softclix
• Version Model Number: 08015333001
• Catalog Number: 08015333001
• 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: 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	00365702702240 [Primary]

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

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: 2022-10-27
• Device Publish Date: 2022-10-19

On-Brand Devices [Accu-Chek Coaguchek Softclix]

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• 00365702702240: CoaguChek Softclix Lancets USA 10ct
• 10365702702162: CoaguChek XS SC Lancing Device Kit 12/cs
• 10365702562100: CoaguChek Softclix Lancets 25ct 100/cs