GUDID 00848838023743

REMEL, INC.

Acridine orange solution IVD

• Primary Device ID: 00848838023743
• NIH Device Record Key: ba632175-c380-4510-98f9-7862af6c01bc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R21502
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• Device Count: 50
• 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	00848838023743 [Primary]
GS1	00848838099830 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920974

FDA Product Code

• JFO: Fluorometric, Calcium

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.

• 00848838003158 - Strep Selective II Agar: 2026-01-26
• 00848838059865 - ^BM^ PK/50 OXIDASE TEST: 2026-01-26 ^BM^ PK/50 OXIDASE TEST
• 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