VitalScreen Reagent 1

GUDID 54119670017674

VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm vitality by dye exclusion. The kit consist of 20ml of

Fertipro NV

Eosin Y solution IVD

• Primary Device ID: 54119670017674
• NIH Device Record Key: 4f1899e4-c6ce-4f80-875d-bc87577f5fc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalScreen Reagent 1
• Version Model Number: VITAL_1
• Company DUNS: 373904101
• Company Name: Fertipro NV
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	54119670017674 [Primary]

FDA Product Code

• LED: Stains, Chemical Solution

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: 2018-09-24
• Device Publish Date: 2018-08-22

On-Brand Devices [VitalScreen Reagent 1]

• 54119670017674: VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm
• 05411967001767: VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm