G210 InviCell Standard Incubator K59500

GUDID 05060554120123

IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART) procedures.

RESEARCH INSTRUMENTS LIMITED

Assisted reproduction heater/incubator

• Primary Device ID: 05060554120123
• NIH Device Record Key: 12fc5c7f-231d-401e-bab5-c76dcf4ea736
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G210 InviCell Standard Incubator
• Version Model Number: G210
• Catalog Number: K59500
• 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: true
• 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	05060554120123 [Primary]

FDA Product Code

• PUB: Accessory, Assisted Reproduction, Exempt

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: 2024-09-27
• Device Publish Date: 2024-09-19

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