ComASP 75009U

GUDID 08058951160436

LIOFILCHEM SRL

Antibacterial minimum inhibitory concentration (MIC) IVD

• Primary Device ID: 08058951160436
• NIH Device Record Key: 72658733-a2dd-4847-a5ac-19dc4816de2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComASP
• Version Model Number: ComASP Cefiderocol 0.008-128
• Catalog Number: 75009U
• Company DUNS: 435342134
• Company Name: LIOFILCHEM SRL
• 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: true
• 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	08058951160436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230479

FDA Product Code

• JWY: Manual Antimicrobial Susceptibility Test Systems

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: 2023-06-08
• Device Publish Date: 2023-05-31

Devices Manufactured by LIOFILCHEM SRL

• 08055182878567 - Liofilchem Antibiotic Disc: 2025-07-23
• 18055182878571 - Liofilchem Antibiotic Disc: 2025-07-23
• 18055182873378 - Liofilchem MTS (MIC Test Strip): 2025-03-27
• 08055182873364 - Liofilchem MTS (MIC Test Strip): 2025-03-27
• 08058951160436 - ComASP: 2023-06-08
• 08058951160436 - ComASP: 2023-06-08
• 08055182870127 - Liofilchem MTS (MIC Test Strip): 2022-02-07
• 08055182870158 - Liofilchem MTS (MIC Test Strip): 2022-02-07
• 08055182870189 - Liofilchem MTS (MIC Test Strip): 2022-02-07