AVENIO Edge System 09283234001

GUDID 07613336180112

Roche Molecular Systems, Inc.

Laboratory container/microscope slide robotic transfer system IVD

• Primary Device ID: 07613336180112
• NIH Device Record Key: 78b01cf5-ada7-43a4-b870-d12cdae42c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVENIO Edge System
• Version Model Number: 09283234001
• Catalog Number: 09283234001
• Company DUNS: 117676383
• Company Name: Roche Molecular Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	07613336180112 [Primary]

FDA Product Code

• JQW: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

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: 2025-04-02
• Device Publish Date: 2025-03-25

Devices Manufactured by Roche Molecular Systems, Inc.

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• 07613336155790 - AcfS L and D Equipment Installation Bundle: 2025-02-07
• 07613336172353 - AcfS Library Robot: 2025-02-07
• 07613336172360 - AcfS Detection Robot: 2025-02-07
• 00875197006896 - cobas HPV Positive Control Kit: 2024-06-14
• 00875197006889 - cobas HPV: 2024-06-13
• 04015630936540 - cobas p630 Pre-Analytical Pipettor: 2022-09-16