Enova Illumination

Basic Information

• Brand Name: Enova Illumination
• Primary DI: 00810186670269
• Version / Model: 90095-001
• Company Name: Enova Illumination, Inc.
• Labeler DUNS: 080805136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-08
• Public Version: 1
• Public Version Date: 2026-04-16
• Public Version Status: New
• Public Device Record Key: 69e7f369-9a18-4fb2-849c-6105673b2618

Device Description

Quantum Warm Standard LED Headlight System Contains the following items, by Enova part number and UDI: Part Name Part No. UDI Quantum Warm lamp 80085 00850025993579 Carrying Case 80034-001 00850025993678 PP4 80201-001 00850025993616 Gray Twist Cable 80302-001 00850025993692 Battery Belt 80500-001 00850025993722 Single Charger 80101-001 00850025993623 C-13 Power Cord (Type B)* 80150-001 00850025993739 C-13 Power Cord (Type C)* 80150-00C 00810186670214 C-13 Power Cord (Type G)* 80150-00G 00810186670139 C-13 Power Cord (Type I)* 80150-00I 00810186670207 *One power cord per system; style depends on region to which the unit is sold.

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	886.4335	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	No	Active
32036	Headband, reusable	A device designed to be worn on the head of a healthcare provider for the mounting of another device, most commonly a head-worn light or a binocular indirect ophthalmoscope (BIO), so that the mounted device will remain directed in the user's line of vision despite head movement. It is typically adjustable for a custom fit. This is a reusable device.	No	Active
36534	Portable/mobile rechargeable battery pack	A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.	No	Active
45804	Electrical mains power cable	An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.	No	Active
46807	Head-worn lamp	An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.	No	Active
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	No	Active
62868	Medical capital equipment storage bag/case	A non-sterile, portable, protective container intended to be used by a healthcare provider to store/transport a piece of medical capital equipment (not included) between uses, and may in addition be intended to hold some device components during use; it is not intended to be worn by a patient to hold a personal medical device. It is a durable bag or case with a padded interior intended to prevent damage to medical devices. It is often designed to contain a specific type of device, however it does not include specific parent-device-supportive medical accessories, and is not intended to shield radiation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810186670269	GS1