FDA.reportPublic FDA data

Nanodropper

Primary DI
00860003576106
Brand
Nanodropper
Company
NANODROPPER, INC.
Model
LUNA-100
Catalog number
LUNA-010
Device description
The Nanodropper is an eye drop bottle adaptor. The Nanodropper is for single-bottle use only.
Published
2020-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003576113PackageGS120In Commercial Distribution
10860003576110PackageGS148In Commercial Distribution
00860003576106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003576113008600035761138600035761130860003576113
1086000357611010860003576110
00860003576106008600035761068600035761060860003576106

GMDN Terms#

Term, Definition table
TermDefinition
Eye dropper bottle nozzle adaptorA nozzle extension intended to be fitted to an eye dropper bottle to decrease the droplet size of an eye irrigation/treatment solution during self-administration. It is intended to be used for the expected duration of the content of a single bottle. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
999-999-9999info@nanodropper.com

Regulatory Flags#

DUNS number
081371550
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003576120Nanodropper B14B14LUNA-B142024-10-22
00860003576137Nanodropper B14B14LUNA-B142024-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18859299184705SMARTeZ Fluid Transfer SetEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKYX2026-04-08
08809692500285Dr.INVIVOROKIT HEALTHCARE Inc.KYX2026-04-02
00008279897857Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
30827989000354Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-09-16
10827989003924Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003931Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003948Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003955Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989000381Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989000404Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003429Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003801Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-20
10827989000398Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
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10827989000336Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
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10827989001333Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16