Liquid Stuarts,Dual Swab PK/500

GUDID 00848838066900

REMEL, INC.

General specimen collection kit

• Primary Device ID: 00848838066900
• NIH Device Record Key: 76dbcd51-6a72-4380-b417-ab11a8cc30cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liquid Stuarts,Dual Swab PK/500
• Version Model Number: R723120
• 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	00848838066900 [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

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