Liquid Amies,Dual Swab PK/50

GUDID 00848838066856

REMEL, INC.

General specimen collection kit

• Primary Device ID: 00848838066856
• NIH Device Record Key: df5169d0-0246-4653-a6bf-a0ee17127abc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liquid Amies,Dual Swab PK/50
• Version Model Number: R723095
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• Device Count: 1
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838066856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943499

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-26
• Device Publish Date: 2025-06-18

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