PD-1

Basic Information

• Brand Name: PD-1
• Primary DI: 00628308210558
• Version / Model: PD-1
• Company Name: INNOVA Medical Ophthalmics Inc
• Labeler DUNS: 243325332
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-31
• Public Version: 1
• Public Version Date: 2026-04-08
• Public Version Status: New
• Public Device Record Key: b0b9a71e-3486-4ce2-9afb-00ff529a234e

Device Description

Pupilometer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HLH	Pupillometer, Manual	Ophthalmic	886.1700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67759	Interpupillary distance meter, electronic	An electrically-powered, ophthalmic instrument, intended for use by a healthcare provider in a clinical setting to objectively measure the distance between the pupils of eyes, typically to ensure proper alignment when fitting spectacles. Also known as a pupilometer, it is a hand-held device with controls and display(s) intended to show the distance measurement.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628308210558	GS1