Evie EK002

GUDID 17290016876021

Slow Release Insemination Catheter

FERTILIGENT LTD

Assisted reproduction transfer catheter/set

• Primary Device ID: 17290016876021
• NIH Device Record Key: 01bdbb34-6781-460a-801a-5927dd3de015
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evie
• Version Model Number: EK002
• Catalog Number: EK002
• Company DUNS: 533729471
• Company Name: FERTILIGENT LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016876024 [Primary]
GS1	17290016876021 [Package]; Contains: 07290016876024; Package: Box [3 Units]; In Commercial Distribution

FDA Product Code

• MQF: Catheter, Assisted Reproduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-11-09

On-Brand Devices [Evie]

• 17290016876021: Slow Release Insemination Catheter
• 07290016876017: Slow Release Insemination Catheter