FDA.reportPublic FDA data

LIPIVIEW OCULAR SURFACE INTERFEROMETER

Primary DI
00859623006513
Brand
LIPIVIEW OCULAR SURFACE INTERFEROMETER
Company
TEARSCIENCE, INC.
Model
LVI-1001
Catalog number
100000
Device description
ASSEMBLY PKGD LIPIVIEW 1 - INTL
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, slit-lamp, ac-powered
HKICamera, ophthalmic, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859623006513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859623006513008596230065138596230065130859623006513

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic interferometerA mains electricity (AC-powered) optical device intended for measurement of the tear film lipid layer using white light image/video capture interferometry. It includes patient head/chin supports, controls, and software intended to enable interferometry analysis in conjunction with images/video of the tear film.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)266-4543JJV-US-SurgicalOrders@its.jnj.com

Regulatory Flags#

DUNS number
791626901
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859623006117LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)LFD-10002210002016-09-23
00859623006315LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLELFD-20002210502016-12-24
00859623006216LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)LFD-11002210012016-09-23
00859623006414LIPIFLOW SYSTEM CONSOLELFTP-10002100002016-09-23
00859623006018MEIBOMIAN GLAND EVALUATORMGE-10013000012018-12-20
00859623006001MEIBOMIAN GLAND EVALUATORMGE-10003000002018-12-20
20859623006135LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)LFD-10002210002016-09-23
20859623006333LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLELFD-20002210502016-12-24
00859623006612LIPIVIEW II OCULAR SURFACE INTERFEROMETELVI-20001001002016-09-23
00859623006711LIPIFLOW SYSTEM ACTIVATOR II CABLE KITCBL-20002401002016-12-24
00859623006919MEIBOMIAN GLAND EVALUATORDMI-10004000002016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00857253006101Phoenix ICON with Training KitPhoenix ClinicalHKI2026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalHKI2026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
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