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

• 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