Accu-Chek Fastclix 09917756001

GUDID 10365702702803

Accu-Chek Fastclix Kit Canada

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable

• Primary Device ID: 10365702702803
• NIH Device Record Key: 6b72fb30-514c-4d2b-aedb-47fad59190d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Fastclix
• Version Model Number: 09917756001
• Catalog Number: 09917756001
• 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	00365702702806 [Primary]
GS1	10365702702803 [Package]; Contains: 00365702702806; Package: [12 Units]; In Commercial Distribution

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: 2023-03-30
• Device Publish Date: 2023-03-22

On-Brand Devices [Accu-Chek Fastclix]

• 04015630083923: Accu-Chek Fastclix 6 Lancet Drum Bulk 100
• 04015630065615: Accu-Chek Fastclix Device Bulk 100
• 00365702702219: Accu-Chek Fastclix AST Kit USA
• 00365702481107: Accu-Chek Fastclix MO/RP/AST Kit USA
• 00365702291102: Accu-Chek Fastclix 102 Lancets DME 12/cs
• 00365702288102: Accu-Chek Fastclix 102 Lancets Rtl 12/cs
• 10365702702803: Accu-Chek Fastclix Kit Canada