Accu-Chek Fastclix 05353815001

GUDID 00365702293106

Accu-Chek FastClix 204 Lancets (CDN, US)

Roche Diabetes Care GmbH

Manual blood lancing device, reusable

• Primary Device ID: 00365702293106
• NIH Device Record Key: d957dbd8-1dff-41b8-9298-eff96f61dc9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Fastclix
• Version Model Number: 05353815001
• Catalog Number: 05353815001
• Company DUNS: 313212471
• Company Name: Roche Diabetes Care GmbH
• 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: 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	00365702293106 [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: 2023-02-13
• Device Publish Date: 2023-02-03

On-Brand Devices [Accu-Chek Fastclix]

• 00365702293106: Accu-Chek FastClix 204 Lancets (CDN, US)
• 00365702292109: Accu-Chek Fastclix 102 Lancets (CDN, US)