VERSATREK M 528 W/22 DRAWERS

GUDID 00848838096747

REMEL, INC.

Blood culture analyser IVD

• Primary Device ID: 00848838096747
• NIH Device Record Key: e68fcf8c-1d4b-40b7-a663-c9eef7dfc2cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSATREK M 528 W/22 DRAWERS
• Version Model Number: Y52822M
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838096747 [Primary]

FDA Product Code

• MDB: System, Blood Culturing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-27
• Device Publish Date: 2023-09-19

Devices Manufactured by REMEL, INC.

• 00848838023729 - REMEL: 2024-12-12 Reagent QC Kit KT/30TST
• 00848838058455 - Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM): 2024-11-21
• 00848838003240 - REMEL: 2024-11-07 Tergitol 7 Agar w/TTC 10/PK
• 00848838007736 - REMEL: 2024-11-07 Lysozyme Broth (5ml) 20/PK
• 00842558116419 - ACT I Transport PK/10: 2024-08-14
• 00842558116426 - ACT II Transport PK/10: 2024-08-14
• 00842558116433 - ACT II Dual Transport PK/10: 2024-08-14
• 05032384519903 - ProSpecT: 2024-08-06 ProSpecT C. diff Toxin A/B MP KT/96TST