d-Nav®

GUDID 00860001044201

Hygieia d-Nav System Phone App - Apple iOS Operating System

HYGIEIA, INC.

Calculator, programmable

• Primary Device ID: 00860001044201
• NIH Device Record Key: 48d0b689-0512-4324-b1bf-ad91f248f156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: d-Nav®
• Version Model Number: V1m00b054i
• Company DUNS: 073601434
• Company Name: HYGIEIA, INC.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 8888214497
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001044201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181916

FDA Product Code

• NDC: Calculator, Drug Dose

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: 2019-04-15
• Device Publish Date: 2019-04-05

On-Brand Devices [d-Nav®]

• 00860001044218: Hygieia d-Nav System Phone App - Android Operating System
• 00860001044201: Hygieia d-Nav System Phone App - Apple iOS Operating System