VERSATREK 528 W/20 DRAWERS/CTRL M

GUDID 00848838096693

REMEL, INC.

Blood culture analyser IVD

• Primary Device ID: 00848838096693
• NIH Device Record Key: d608fe99-f27f-43ce-8429-78f1c81dd3aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSATREK 528 W/20 DRAWERS/CTRL M
• Version Model Number: Y52820
• Company DUNS: 065769564
• Company Name: REMEL, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838096693 [Primary]

FDA Product Code

• MDB: System, Blood Culturing

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: 2023-08-03
• Device Publish Date: 2023-07-26

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• 00848838066672 - Amies Clear Gel,Single Swab PK/50: 2025-06-26
• 00848838066689 - Amies Clear Gel,Dual Swab PK/500: 2025-06-26
• 00848838066696 - Amies Clear Gel,Dual Swab PK/50: 2025-06-26