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Zenlens Patient Kit

FDA UDI

Class II (US FDA UDI)

by Bausch & Lomb Incorporated

Identity

Trade Name
Zenlens Patient Kit FDA UDI
Generic Name
Contact lens care kit FDA UDI
Device Name
Patient Kit including ScleralFil (3x 10ml), DMV inserter/remover, Boston SIMPLUS Multi-Action Kit FDA UDI
Model / Reference
ZPK8 FDA UDI
Description
Patient Kit including ScleralFil (3x 10ml), DMV inserter/remover, Boston SIMPLUS Multi-Action Kit FDA UDI

Identifiers

Catalog Number
ZPK8 FDA UDI
Primary DI / UDI-DI
00196527447258 FDA UDI
FDA Product Code
MRC FDA UDI
KYE FDA UDI
GMDN Term
Contact lens care kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.5918 FDA UDI
886.5420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Contact lens care kitRigid contact lens inserter/removerRigid contact lens cleaning solution

Zenlens Patient Kit by Bausch & Lomb Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid contact lens cleaning solution.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bausch & Lomb Incorporated

Sources (1)

  • FDA UDI 91b9daa9-eab3-4566-be88-a6ad99a67eef 34 fields · synced Jun 8, 2026