BactiSwab (Dry) CS/500

GUDID 00842558116501

Remel Inc.

General specimen collection kit IVD, clinical

• Primary Device ID: 00842558116501
• NIH Device Record Key: a0a08e00-6b32-4614-a374-27babd7aaff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BactiSwab (Dry) CS/500
• Version Model Number: R120170
• Company DUNS: 118161628
• 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: 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	00842558116501 [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: 2024-08-22
• Device Publish Date: 2024-08-14

Devices Manufactured by Remel Inc.

• 00842558116501 - BactiSwab (Dry) CS/500: 2024-08-22
• 00842558116501 - BactiSwab (Dry) CS/500: 2024-08-22
• 00848838018510 - R12576 M4RTUniversal Plus Swab Kit PK/100: 2024-04-08
• 00842558109718 - MicroTest M4RT: 2023-01-13 M4RT(3ml) Dual Swab KIT
• 00842558110202 - MicroTest M4RT: 2023-01-13 M4RT(3ml) 2NPG Swab KIT
• 00842558111209 - MicroTest M4RT: 2023-01-13 M4RT(3ml) w/o Beads PK/50
• 00842558112602 - MicroTest M4RT: 2023-01-13 M4RT (3ml) no BEADS Nasal Swab Kit w/bag
• 00848838078132 - MicroTest: 2023-01-13 M6 (3.0ml) PK/72