GUDID 00848838002441

REMEL, INC.

Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

• Primary Device ID: 00848838002441
• NIH Device Record Key: d64d1b73-09ac-4fc1-8018-4bbe021755f8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R01621
• 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	00848838002441 [Primary]
GS1	00848838099489 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960313

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

Devices Manufactured by REMEL, INC.

• 00842558116402 - BactiSwab Dry PK/100: 2025-06-27
• 00848838066665 - Amies Clear Gel,Single Swab PK/500: 2025-06-26
• 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
• 00848838066702 - Amies Clear Gel,Wire Shaft Swab PK/100: 2025-06-26
• 00848838066719 - Amies Clear Gel,Wire Shaft PK/50: 2025-06-26
• 00848838066757 - Amies Charcoal Gel,Single Swab PK/50: 2025-06-26