Accu-Chek Fastclix 05360188001

GUDID 00365702291102

Accu-Chek Fastclix 102 Lancets DME 12/cs

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable

• Primary Device ID: 00365702291102
• NIH Device Record Key: 67998aa5-3685-4f5a-90ba-7b1e84b0d95e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Fastclix
• Version Model Number: 05360188001
• Catalog Number: 05360188001
• 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	00365702291102 [Primary]
GS1	10365702291109 [Package]; 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: 2022-10-05
• Device Publish Date: 2022-09-27

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