BactiSwab Dry PK/100

GUDID 00842558116402

REMEL, INC.

General specimen collection kit IVD, clinical

• Primary Device ID: 00842558116402
• NIH Device Record Key: f35ec342-31ba-4f99-aef3-3e2718642e5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BactiSwab Dry PK/100
• Version Model Number: R723135
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00842558116402 [Primary]

FDA Product Code

• KXG: Applicator, Absorbent Tipped, Sterile

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: 2025-06-27
• Device Publish Date: 2025-06-19

Devices Manufactured by REMEL, INC.

• 00842558116402 - BactiSwab Dry PK/100: 2025-06-27
• 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