FDA.reportPublic FDA data

Biotrue® Hydration Boost Contact Lens Rehydrating Drops

Primary DI
00310119022771
Brand
Biotrue® Hydration Boost Contact Lens Rehydrating Drops
Company
Bausch & Lomb Incorporated
Model
FCP-4371
Catalog number
622277BO
Device description
Preservative Free Lubricating and Rewetting Drops for Contact Lens
Published
2023-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2
MRCProducts, Contact Lens Care, Rigid Gas PermeableOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00310119022771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310119022771003101190227713101190227710310119022771

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens wetting solutionAn aqueous formulation intended to wet contact lenses. The device is dispensed as droplets typically directly on the eyes while the patient wears the contact lenses; it is available in single- or multiple-dose containers. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195515153287Amazon BasicsAMAZON.COM SERVICES LLCLPN2026-08-07
04049584037794WE CARE Multi-Purpose-Solution, 100 mlOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMRC2026-07-30
04049584037794WE CARE Multi-Purpose-Solution, 100 mlOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungLPN2026-07-30
04049584037800WE CARE Multi-Purpose-Solution, 360 mlOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMRC2026-07-30
04049584037800WE CARE Multi-Purpose-Solution, 360 mlOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungLPN2026-07-30
00194346672837EquateWAL-MART STORES, INC.LPN2026-06-23
00194346672844EquateWAL-MART STORES, INC.LPN2026-06-23
04950055206505cleadew GP hydra oneOPHTECS CORPORATIONMRC2026-05-11
04950055206512cleadew GP hydra oneOPHTECS CORPORATIONMRC2026-05-11
00095072096006Up&Up TARGET CORPORATIONMRC2026-04-22
00198168143803 Tangible Fill DRY EYE INNOVATIONS, LLCMRC2026-04-22
00310119041062Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041086Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041420Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041468Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119044230Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119044247Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119304242up & up multipurpose solutionTARGET CORPORATIONLPN2026-01-09
00850013056071VibrantVueDRY EYE INNOVATIONS, LLCMRC2025-12-01
00850013056095VibrantVue DRY EYE INNOVATIONS, LLCMRC2025-12-01
00196527447258Zenlens Patient KitBausch & Lomb IncorporatedMRC2025-06-17
00780707000007HydravueUnited Exchange Corp.LPN2025-05-23
00310119030189renu sensitive multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119030486renu sensitive multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119031186renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119031223renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119032220renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00194346415397EquateWAL-MART STORES, INC.LPN2024-12-05
00713733766173MeijerMEIJER, INC.MRC2024-10-23
00713733766197MeijerMEIJER, INC.MRC2024-10-23