FDA.reportPublic FDA data

Nanodropper B14

Primary DI
00860003576120
Brand
Nanodropper B14
Company
NANODROPPER, INC.
Model
B14
Catalog number
LUNA-B14
Device description
The Nanodropper B14 is an eye drop bottle adaptor. The Nanodropper B14 is for single-bottle use only.
Published
2024-10-22
Public version status
New
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
00860003576137PackageGS120In Commercial Distribution
00860003576120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003576137008600035761378600035761370860003576137
00860003576120008600035761208600035761200860003576120

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
999-999-9999support@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
00860003576137Nanodropper B14B14LUNA-B142024-10-22
00860003576106NanodropperLUNA-100LUNA-0102020-06-25

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
10827989004167Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989000336Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000343Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000350Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000770Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004044Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004051Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004068Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989001098Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001128Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001159Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001180Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001210Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001241Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001272Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001302Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001333Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16