LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) 221000

GUDID 20859623006135

ACTIVATORS (BOX OF 10) US

TEARSCIENCE, INC.

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Primary Device ID20859623006135
NIH Device Record Key607234de-55d5-4a62-8662-a4ed426709dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)
Version Model NumberLFD-1000
Catalog Number221000
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
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
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
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 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859623006117 [Primary]
GS120859623006135 [Package]
Contains: 00859623006117
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 Date2016-09-23

On-Brand Devices [LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)]

00859623006216ACTIVATORS (BOX OF 10) US
20859623006135ACTIVATORS (BOX OF 10) US

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