GUDID 00848838002489

REMEL, INC.

Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

• Primary Device ID: 00848838002489
• NIH Device Record Key: e5fd083c-3241-47ba-ad2a-5793ad4a3851
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R01626
• 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	00848838002489 [Primary]
GS1	00848838099502 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850291

FDA Product Code

• JTZ: Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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