LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE 221050

GUDID 20859623006333

ACTIVATORS (BOX OF 10) US

TEARSCIENCE, INC.

Eyelid thermal pulsation system applicator
Primary Device ID20859623006333
NIH Device Record Key09a06cf3-bc19-42bb-9c4f-7e790857caa3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE
Version Model NumberLFD-2000
Catalog Number221050
Company DUNS791626901
Company NameTEARSCIENCE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com

Device Dimensions

Pressure6 Pound per Square Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859623006315 [Primary]
GS120859623006333 [Package]
Contains: 00859623006315
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

ORZEyelid thermal pulsation system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2020-03-05
Device Publish Date2016-12-24

Devices Manufactured by TEARSCIENCE, INC.

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00859623006018 - MEIBOMIAN GLAND EVALUATOR2020-03-05 MEIBOMIAN GLAND EVALUATOR - AU,CA,US
20859623006135 - LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)2020-03-05 ACTIVATORS (BOX OF 10) US
00859623006216 - LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)2020-03-05 ACTIVATORS (BOX OF 10) US
20859623006333 - LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE2020-03-05ACTIVATORS (BOX OF 10) US
20859623006333 - LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE2020-03-05 ACTIVATORS (BOX OF 10) US
00859623006414 - LIPIFLOW SYSTEM CONSOLE2019-10-04 ASSEMBLY PKGD LIPIFLOW - US
00859623006513 - LIPIVIEW OCULAR SURFACE INTERFEROMETER2019-10-04 ASSEMBLY PKGD LIPIVIEW 1 - INTL
00859623006612 - LIPIVIEW II OCULAR SURFACE INTERFEROMETE2019-10-04 ASSEMBLY PKGD LIPIVIEW-2 - US

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