CODA K59549

GUDID 05060554120024

The Coda Air Purification System will be used as an accessory item during assisted reproductive procedures

RESEARCH INSTRUMENTS LIMITED

Assisted reproduction heater/incubator

• Primary Device ID: 05060554120024
• NIH Device Record Key: cc53f3bb-83ae-4c5d-9105-ce69d4576ec6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODA
• Version Model Number: K59549 Coda Inline Filter for G185 US
• Catalog Number: K59549
• Company DUNS: 536139413
• Company Name: RESEARCH INSTRUMENTS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	05060554120024 [Primary]

FDA Product Code

• MQG: Accessory, Assisted Reproduction

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: 2024-09-30
• Device Publish Date: 2024-09-20

Devices Manufactured by RESEARCH INSTRUMENTS LIMITED

• 05060554120956 - K-Systems: 2025-03-05 IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro f
• 05060554120963 - K-Systems: 2025-03-05 IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro f
• 00888937014488 - TITAN: 2024-09-30 In Vitro Fertilization IVF Workstation
• 00888937014587 - MARS: 2024-09-30 In Vitro Fertilization IVF Workstation
• 00888937014600 - MARS: 2024-09-30 In Vitro Fertilization IVF Workstation
• 00888937014648 - MARS: 2024-09-30 In Vitro Fertilization IVF Workstation
• 00888937014655 - TITAN: 2024-09-30 In Vitro Fertilization IVF Workstation
• 00888937014662 - TITAN: 2024-09-30 In Vitro Fertilization IVF Workstation