AccessGUDID - DEVICE: LIPIFLOW SYSTEM CONSOLE (00859623006414)

GUDID

Device Identifier (DI) Information

Brand Name: LIPIFLOW SYSTEM CONSOLE
Version or Model: LFTP-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 210000
Company Name: TEARSCIENCE, INC.

Primary DI Number: 00859623006414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791626901 *Terms of Use

Device Description: ASSEMBLY PKGD LIPIFLOW - US

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58217	Eyelid thermal pulsation system control unit	An electrically-powered ophthalmic device intended to control the application of heat and pressure (e.g., intermittent pressure massage) applied to the eyelids during treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It typically includes controls, integrated software, and a visual display unit (VDU) and is designed to control the heat and pressure supply that are applied via an attached applicator (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORZ	Eyelid thermal pulsation system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Pressure: 6 Pound per Square Inch

Device Record Status

Public Device Record Key: e7d681fd-96d8-45fd-b5fb-235fb99f7fec
Public Version Date: January 20, 2025
Public Version Number: 7
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES