RELION 09556672001

GUDID 00365702702660

Relion Platinum Lancing Device

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable

• Primary Device ID: 00365702702660
• NIH Device Record Key: 8beb33b5-9f67-4ddc-a7e9-6ba0d4dfb4b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELION
• Version Model Number: 09556672001
• Catalog Number: 09556672001
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00365702702660 [Primary]

FDA Product Code

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

Sterilization

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

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

Devices Manufactured by Roche Diagnostics Operations, Inc.

• 00365702702417 - ACCU-CHEK GUIDE LINK: 2023-09-29 ACCU-CHEK GUIDE LINK MG/DL 118
• 10365702702889 - ACCU-CHEK GUIDE LINK: 2023-09-29 ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US
• 10365702702476 - ACCU-CHEK GUIDE LINK: 2023-09-14 Accu-Chek Guide Link SC mg/dL
• 10365702702537 - ACCU-CHEK GUIDE LINK: 2023-09-14 Accu-Chek Guide Link MO Replacement US
• 10365702702803 - Accu-Chek Fastclix: 2023-03-30 Accu-Chek Fastclix Kit Canada
• 10365702702827 - Accu-Chek Softclix: 2023-03-30 Accu-Chek Softclix Kit Canada
• 00365702702684 - Instant White Label: 2022-10-31 IWL Lancets 10ct
• 10075537257897 - Accu-Chek Safe-T-Pro: 2022-10-27 Accu-Chek Safe-T-Pro Plus 200ct