BACTI-SWAB R124022

GUDID 00848838018282

ACT II Dual Transport PK/10

REMEL, INC.

General specimen collection kit IVD, clinical

• Primary Device ID: 00848838018282
• NIH Device Record Key: a56e6bba-b70b-453a-8896-45f17944e173
• Commercial Distribution Discontinuation: 2024-03-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BACTI-SWAB
• Version Model Number: R124022
• Catalog Number: R124022
• 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	00848838018282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K965152

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: 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