GUDID 00848838018817

REMEL, INC.

Fungal antimicrobial susceptibility culture medium IVD

• Primary Device ID: 00848838018817
• NIH Device Record Key: 156b24d9-c0a1-499f-a0b1-f4eb64906321
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Y3462
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• Device Count: 10
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8002556730
• Email: ITechnicalSupport@remel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838018817 [Primary]
GS1	00848838099717 [Unit of Use]

FDA Product Code

• NGZ: Susceptibility Test Plate, Antifungal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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