LIPIFLOW SYSTEM CONSOLE 210000

GUDID 00859623006414

ASSEMBLY PKGD LIPIFLOW - US

TEARSCIENCE, INC.

Eyelid thermal pulsation system control unit
Primary Device ID00859623006414
NIH Device Record Keye7d681fd-96d8-45fd-b5fb-235fb99f7fec
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIPIFLOW SYSTEM CONSOLE
Version Model NumberLFTP-1000
Catalog Number210000
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com
Phone+1(877)266-4543
EmailJJV-US-SurgicalOrders@its.jnj.com

Device Dimensions

Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch
Pressure6 Pound per Square Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859623006414 [Primary]

FDA Product Code

ORZEyelid thermal pulsation system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-04
Device Publish Date2016-09-23

Devices Manufactured by TEARSCIENCE, INC.

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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 (DISPOSABLE2020-03-05 ACTIVATORS (BOX OF 10) US
00859623006414 - LIPIFLOW SYSTEM CONSOLE2019-10-04ASSEMBLY PKGD LIPIFLOW - 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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