ZyMot ZPH1002

GUDID 00860451001236

Sperm Separation Device

DXNOW, INC.

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