K-Systems K61500

GUDID 05060554120307

Assisted Reproduction Accessories

RESEARCH INSTRUMENTS LIMITED

Assisted reproduction heater/incubator

• Primary Device ID: 05060554120307
• NIH Device Record Key: 49ce8761-7eac-4ec0-980e-6bd8e82c2a79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Systems
• Version Model Number: G210 InviCell US Incubator
• Catalog Number: K61500
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060554120307 [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: 2019-03-27
• Device Publish Date: 2019-03-19

On-Brand Devices [K-Systems]

• 05060554120307: Assisted Reproduction Accessories
• 05060554120291: Assisted Reproduction Accessories
• 05060554120048: Assisted Reproduction Accessories
• 05060554120017: Assisted Reproduction Accessories