FDA.reportPublic FDA data

Tangible Fill

Primary DI
00198168143803
Brand
Tangible Fill
Company
DRY EYE INNOVATIONS, LLC
Model
Tangible Fill Saline
Device description
Sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial.
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRCProducts, Contact Lens Care, Rigid Gas Permeable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRCProducts, Contact Lens Care, Rigid Gas PermeableOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198168143803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198168143803001981681438031981681438030198168143803

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens rinsing solutionA sterile solution intended to be used to rinse debris or chemical agents from contact lenses (soft or rigid) prior to insertion; it may be intended to be used during storage or heat disinfection of contact lenses, or to dilute other contact lens solutions (e.g., contact lens protein-removal solution). It is an aqueous saline solution containing preservatives [e.g., edetate disodium (EDTA)] and buffering agents; it does not contain disinfecting, protein-removal, cleaning, or wetting agents. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
(855) 551-2656rhayes@myvibrantvue.com

Regulatory Flags#

DUNS number
043208431
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013056071VibrantVueVibrantVue Saline2025-12-01
00850013056095VibrantVue VibrantVue Saline Samples2025-12-01
00850013056057VibrantVue2020.031HC22023-11-15
00850013056064VibrantVue2020.031HC22023-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04950055206505cleadew GP hydra oneOPHTECS CORPORATIONMRC2026-05-11
04950055206512cleadew GP hydra oneOPHTECS CORPORATIONMRC2026-05-11
00095072096006Up&Up TARGET CORPORATIONMRC2026-04-22
00850013056071VibrantVueDRY EYE INNOVATIONS, LLCMRC2025-12-01
00850013056095VibrantVue DRY EYE INNOVATIONS, LLCMRC2025-12-01
00196527447258Zenlens Patient KitBausch & Lomb IncorporatedMRC2025-06-17
00713733766173MeijerMEIJER, INC.MRC2024-10-23
00713733766197MeijerMEIJER, INC.MRC2024-10-23
00198168596739Tangible Clean Sample BottleTANGIBLE SCIENCE, INC.MRC2024-04-22
00198168983577Tangible CleanTANGIBLE SCIENCE, INC.MRC2024-04-22
00860005853410Aqua Naina Sterile Saline Solution Chemtex USA Inc.MRC2024-03-20
00310119022771Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedMRC2023-10-25
00310119303696ScleralFilBausch & Lomb IncorporatedMRC2023-07-05
00364108422301LensGieneOPTICS LABORATORY, INC.MRC2023-05-05
00364108422011LensGieneOPTICS LABORATORY, INC.MRC2023-05-05
00310119022498Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedMRC2023-04-27
00850012123019NutrifillCONTAMAC SOLUTIONS, INC.MRC2022-08-04
00830002000018PuriLens Plus Preservative Free SalineLIFESTYLE CO INC, THEMRC2021-09-24
00830002000087PuriLens Plus Preservative Free SalineLIFESTYLE CO INC, THEMRC2021-09-24
00830002000094PuriLens Plus Preservative Free SalineLIFESTYLE CO INC, THEMRC2021-09-24
00681131176361EquateWAL-MART STORES, INC.MRC2020-11-17
00681131179119EquateWAL-MART STORES, INC.MRC2020-11-17
00681131179126EquateWAL-MART STORES, INC.MRC2020-11-17
00850012123002NutrifillCONTAMAC SOLUTIONS, INC.MRC2020-08-20
00310119303818up & up rigid gas permeable contact lens conditioning solutionTARGET CORPORATIONMRC2020-06-05
00310119054536Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00310119054543Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00310119054550Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00047113709338CLEAR CAREAlcon Laboratories, Inc.MRC2020-02-25
00858961791037up & up rigid gas permeable contact lens conditioning solutionTARGET CORPORATIONMRC2019-04-23