K-Systems K59500

GUDID 05060554120963

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: 05060554120963
• NIH Device Record Key: 1ad108a0-6df9-4098-8959-709afa2de7c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Systems
• Version Model Number: G210 InviCell
• 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	05060554120963 [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: 2025-03-05
• Device Publish Date: 2025-02-25

On-Brand Devices [K-Systems]

• 05060554120307: Assisted Reproduction Accessories
• 05060554120291: Assisted Reproduction Accessories
• 05060554120048: Assisted Reproduction Accessories
• 05060554120017: Assisted Reproduction Accessories
• 05060554120963: IVF Incubator. Intended to establish a suitable environment for the development of human embryo
• 05060554120956: IVF Incubator. Intended to establish a suitable environment for the development of human embryo