iChem Velocity 700-7177-001

GUDID 10837461001751

2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA) 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated Velocity Computerless System Ready (NA) "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7106 COMPUTERLESS VELOCITY" "2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-7190 IRICELL 1500 (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-3049 iRICELL 2000 Pro (NA)" 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7714 iRICELL 2000 Plus (NA) "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7713 iRICELL 3000 Plus (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3079 iRICELL 3000 Pro (NA) w load/unload" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3048 iRICELL 3000 Pro (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3080 iRICELL 3000 PRO w/ Load/Unload" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3050 iRICELL 1000 Pro (NA)"

IRIS INTERNATIONAL, INC.

Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory

• Primary Device ID: 10837461001751
• NIH Device Record Key: 92f2c866-f39a-4047-a552-81cdc6888d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iChem Velocity
• Version Model Number: Back-Integrated Velocity (NA)
• Catalog Number: 700-7177-001
• Company DUNS: 098240690
• Company Name: IRIS INTERNATIONAL, 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: false
• 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	10837461001751 [Primary]

FDA Product Code

• KQO: Automated Urinalysis System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-09-16
• Device Publish Date: 2016-09-07

On-Brand Devices [iChem Velocity]

• 10837461009375: "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automated Urine Chemis
• 10837461001751: 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity