FDA.reportPublic FDA data

Zenlens Patient Kit

Primary DI
00196527447258
Brand
Zenlens Patient Kit
Company
Bausch & Lomb Incorporated
Model
ZPK8
Catalog number
ZPK8
Device description
Patient Kit including ScleralFil (3x 10ml), DMV inserter/remover, Boston SIMPLUS Multi-Action Kit
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYEInserter/Remover Contact LensOphthalmic1
MRCProducts, Contact Lens Care, Rigid Gas PermeableOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196527447258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196527447258001965274472581965274472580196527447258

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens care kitA collection of devices and supplies used in the general care of reusable contact lenses. This device is typically a container (e.g., a carton, pouch, or bag) containing the necessary materials for disinfecting and wetting the contact lenses and for their storage when not in use (e.g., a sterile cleaning solution and a lens case). Some devices may also include the contact lenses as part of the initial kit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770419135Bausch + LombSP7-100344SP7-1003442026-05-11
00757770434268Bausch + LombSP7-100346SP7-1003462026-05-11
00757770652983Bausch + LombSP7-65819SP7-658192026-05-11
00757770683543Bausch + LombSP7-60918SP7-609182026-05-11
00757770683567Bausch + LombSP7-35672SP7-356722026-05-11
00757770688548Bausch + LombSP7-74835SP7-748352026-05-11
00757770714643Bausch + LombSP7-04989SP7-049892026-05-11
00757770714759Bausch + LombSP7-58985SP7-589852026-05-11
10757770529206Bausch + LombBL3124BL31242026-04-30
20757770455878Bausch + LombE3671E36712026-04-30
20757770457445Bausch + LombMVS 1022MVS 10222026-04-30
20757770457568Bausch + LombN0522 DN0522 D2026-04-30
20757770457650Bausch + LombN2398 3N2398 32026-04-30
20757770457667Bausch + LombN2398 4N2398 42026-04-30
20757770457674Bausch + LombN2398 5N2398 52026-04-30
20757770457759Bausch + LombN4847N48472026-04-30
20757770457766Bausch + LombN6305 7N6305 72026-04-30
20757770457773Bausch + LombN6305 8N6305 82026-04-30
20757770457780Bausch + LombN6305 9N6305 92026-04-30
20757770457803Bausch + LombN6372 7N6372 72026-04-30

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
00198168143803 Tangible Fill DRY EYE INNOVATIONS, LLCMRC2026-04-22
03770020907593ScleralEaseODC INDUSTRIESKYE2026-03-06
03770020907586ScleralEaseODC INDUSTRIESKYE2026-02-21
00850013056071VibrantVueDRY EYE INNOVATIONS, LLCMRC2025-12-01
00850013056095VibrantVue DRY EYE INNOVATIONS, LLCMRC2025-12-01
00713733766173MeijerMEIJER, INC.MRC2024-10-23
00713733766197MeijerMEIJER, INC.MRC2024-10-23
B091230122Silicone Suction Cup (10pk)Gulden Ophthalmics Inc.KYE2024-09-04
B091230120Silicone Suction Cup (10pk)Gulden Ophthalmics Inc.KYE2024-09-04
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
B091230121Silicone Suction Cup (12 pk)Gulden Ophthalmics Inc.KYE2023-07-05
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
00840319716632Hayden MedicalHayden Medical, Inc.KYE2022-08-03
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