FDA.reportPublic FDA data

MEIBOMIAN GLAND EVALUATOR

Primary DI
00859623006919
Brand
MEIBOMIAN GLAND EVALUATOR
Company
TEARSCIENCE, INC.
Model
DMI-1000
Catalog number
400000
Device description
ASSEMBLY PKGD LIPISCAN - US
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
HKICamera, ophthalmic, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859623006919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859623006919008596230069198596230069190859623006919

GMDN Terms#

Term, Definition table
TermDefinition
Meibomian gland cameraA mains electricity (AC-powered) optical device intended for infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands. It includes patient head/chin supports, an IR source(s), IR camera, controls and appropriate software intended to enable analysis of the images; it may include an eyelid everter to assist imaging of the meibomian glands.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 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
00859623006513LIPIVIEW OCULAR SURFACE INTERFEROMETERLVI-10011000002016-09-23
00859623006612LIPIVIEW II OCULAR SURFACE INTERFEROMETELVI-20001001002016-09-23
00859623006711LIPIFLOW SYSTEM ACTIVATOR II CABLE KITCBL-20002401002016-12-24

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