GUDID 00848838004216

REMEL, INC.

VRE/HLARE agar culture medium IVD

• Primary Device ID: 00848838004216
• NIH Device Record Key: 25366e28-8cd5-4086-9911-ad3cf620d9f4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R02474
• 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: true
• 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	00848838004216 [Primary]
GS1	00848838099564 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941443

FDA Product Code

• JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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: 2016-12-09

Devices Manufactured by REMEL, INC.

• 00842558116419 - ACT I Transport PK/10: 2024-08-14
• 00842558116426 - ACT II Transport PK/10: 2024-08-14
• 00842558116433 - ACT II Dual Transport PK/10: 2024-08-14
• 05032384519903 - ProSpecT: 2024-08-06 ProSpecT C. diff Toxin A/B MP KT/96TST
• 00848838002724 - REMEL: 2024-05-14 Pseudomonas P Agar 10/PK
• 00848838009921 - REMEL: 2024-05-14 Thio Med w/o Ind, w/o Dex (5ml) 100/PK
• 00848838009938 - REMEL: 2024-05-14 Thio Med w/o Ind, w/o Dex (5ml) 20/PK
• 00848838001994 - REMEL: 2024-05-13 KBE (Kanamycin Bile Esculin) Agar 15/PK