GUDID 00848838001796

REMEL, INC.

Neiserria species agar culture medium IVD, basic

• Primary Device ID: 00848838001796
• NIH Device Record Key: 59077c7b-360b-4f81-b2bd-8d42dcf622d2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R01460
• 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	00848838001796 [Primary]
GS1	00848838099458 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954986

FDA Product Code

• JTY: Culture Media, For Isolation Of Pathogenic Neisseria

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.

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• 00848838000614 - REMEL: 2024-04-17 Blood Agar,5% Sheep Blood 150/PK
• 00848838000638 - REMEL: 2024-04-17 Blood Agar,5% Sheep Blood 15/PK
• 00848838000980 - REMEL: 2024-04-17 Brucella Agar, LKV 10/PK
• 00848838001154 - REMEL: 2024-04-17 Chocolate Agar 150/PK
• 00848838001215 - REMEL: 2024-04-17 Chocolate Agar 15/PK
• 00848838001352 - REMEL: 2024-04-17 Columbia CNA w/5% Sheep Blood 150/PK