ZyMot ZPH1002

GUDID 00860451001236

Sperm Separation Device

DXNOW, INC.

Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool Assisted reproduction microtool

• Primary Device ID: 00860451001236
• NIH Device Record Key: e61f8d5f-d338-4dfe-a005-ea76a65df5e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZyMot
• Version Model Number: ICSI
• Catalog Number: ZPH1002
• Company DUNS: 078815798
• Company Name: DXNOW, INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860451001205 [Primary]
GS1	00860451001236 [Unit of Use]
GS1	10860451001233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173075

FDA Product Code

• MQK: Labware, Assisted Reproduction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [ZyMot]

• 00860451001250: Sperm Separation Device
• 00860451001243: Sperm Separation Device
• 00860451001236: Sperm Separation Device
• 00860004123903: Sperm Separation Device
• 00860004123941: Sperm Separation Device Natech 3mL 3 pack
• 00860004123934: Sperm Separation Device Natech 3mL 10 pack