FDA.reportPublic FDA data

Mydcombi

Primary DI
00860009909700
Brand
Mydcombi
Company
Eyenovia, Inc.
Model
FG-16427
Device description
A reusable non-sterile component of the MydCombi drug delivery system. Working in conjunction with the Cartridge, this base contains the drive system that allows actuation of the mist. It also contains the power source and interfaces with an external charging source.
Published
2023-06-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNWDilator, Lachrymal
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009909700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009909700008600099097008600099097000860009909700

GMDN Terms#

Term, Definition table
TermDefinition
Battery boxA special container intended to be used to house batteries for protective purposes. This device will typically be portable so that the user can safely carry the power source.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081095537
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995319830V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319847V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319878V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319885V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319892V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319908V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319915V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319922V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319939V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319946V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319953V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319960V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319977V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319984V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
09420060205039haakaaTHINK GREEN LIMITEDKYX2026-09-20
09420060205046haakaaTHINK GREEN LIMITEDKYX2026-09-20