BACTI-SWAB R12015

GUDID 00848838018190

BactiSwab (Dry) PK/100

REMEL, INC.

General specimen collection kit IVD, clinical

• Primary Device ID: 00848838018190
• NIH Device Record Key: a51c9f5e-52ca-4575-8260-0275f0898c10
• Commercial Distribution Discontinuation: 2024-03-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BACTI-SWAB
• Version Model Number: R12015
• Catalog Number: R12015
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838018190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013711

FDA Product Code

• LIO: Device, Specimen Collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-03-29
• Device Publish Date: 2022-12-22

On-Brand Devices [BACTI-SWAB]

• 00848838018282: ACT II Dual Transport PK/10
• 00848838018244: BactiSwab NPG (Mod Stuarts) PK/100
• 00848838018220: BactiSwab II (Mod Stuarts) PK/100
• 00848838018206: BactiSwab (Mod Stuarts) PK/100
• 00848838018190: BactiSwab (Dry) PK/100