FDA.reportPublic FDA data

LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE

Primary DI
00859623006315
Brand
LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE
Company
TEARSCIENCE, INC.
Model
LFD-2000
Catalog number
221050
Device description
ACTIVATORS (BOX OF 10) US
Published
2016-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORZEyelid thermal pulsation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORZEyelid Thermal Pulsation SystemOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859623006333PackageGS110In Commercial Distribution
00859623006315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085962300633320859623006333
00859623006315008596230063158596230063150859623006315

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid thermal pulsation system applicator, single-useAn ophthalmic device designed to apply heat and pressure (intermittent pressure massage) to the outer eyelid surface for treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It consists of two small plates, one positioned under the eyelid, and the other with heating/pulsing elements applied to the outside of the eyelid, and is used with a reusable control unit (not included). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure6Pound per Square Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
791626901
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859623006117LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)LFD-10002210002016-09-23
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
00859623006919MEIBOMIAN GLAND EVALUATORDMI-10004000002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290117524077Tixel i NOVOXEL LTDORZ2026-04-06
07290117524084Tixel i HP NOVOXEL LTDORZ2026-04-06
00380650005748iLuxAlcon Laboratories, Inc.ORZ2026-03-13
00380650005731iLuxAlcon Laboratories, Inc.ORZ2026-03-13
20380650005728iLuxAlcon Laboratories, Inc.ORZ2026-03-13
00858027006549TearCare MGX System - TearCare MGX Technology KitSight Sciences, Inc.ORZ2025-04-30
00858027006297TearCare MGX System - TearCare MGX SmartLidsSight Sciences, Inc.ORZ2025-04-29
00858027006457TearCare System - TearCare SmartHub KitSight Sciences, Inc.ORZ2022-03-03
00858027006495TearCare System - TearCare SmartLidsSight Sciences, Inc.ORZ2022-03-03
00810051250022TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
00810051250077TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
10810051250029TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
10810051250074TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
00864461000401iLuxAlcon Laboratories, Inc.ORZ2018-11-05
00864461000418iLuxAlcon Laboratories, Inc.ORZ2018-11-05
20859623006333LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLETEARSCIENCE, INC.ORZ2016-12-24
00859623006711LIPIFLOW SYSTEM ACTIVATOR II CABLE KITTEARSCIENCE, INC.ORZ2016-12-24
00859623006117LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23
20859623006135LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23
00859623006216LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23
00859623006414LIPIFLOW SYSTEM CONSOLETEARSCIENCE, INC.ORZ2016-09-23