ComASP 75009U

GUDID 08058951160436

LIOFILCHEM SRL

Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD 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

• 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
• 08055182870219 - Liofilchem MTS (MIC Test Strip): 2022-02-07
• 08055182870240 - Liofilchem MTS (MIC Test Strip): 2022-02-07
• 08055182870271 - Liofilchem MTS (MIC Test Strip): 2022-02-07
• 08055182870301 - Liofilchem MTS (MIC Test Strip): 2022-02-07