G210 InviCell Plus Incubator K60000

GUDID 05060554120130

The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments.

RESEARCH INSTRUMENTS LIMITED

Assisted reproduction heater/incubator

• Primary Device ID: 05060554120130
• NIH Device Record Key: 728592f7-b7e2-4643-819a-3ae9647e7682
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G210 InviCell Plus Incubator
• Version Model Number: G210
• Catalog Number: K60000
• 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: 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	05060554120130 [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

• 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
• 00888937014679 - TITAN: 2024-09-30 In Vitro Fertilization IVF Workstation
• 00888937020243 - MARS: 2024-09-30 In Vitro Fertilization IVF Workstation