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Lipiflow System Activator Ii Cable Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 0820-5000
Identity
- Trade Name
- LIPIFLOW SYSTEM CABLE KIT EUDAMEDLIPIFLOW SYSTEM ACTIVATOR II CABLE KIT FDA UDI
- Generic Name
- Eyelid thermal pulsation system cable/tubing FDA UDI
- Device Name
- LIPIFLOW SYSTEM CABLE EUDAMEDKIT CABLE PKGD ACTIVATOR II - US FDA UDI
- Model / Reference
- 0820-5000 EUDAMEDCBL-2000 FDA UDI
- Description
- KIT CABLE PKGD ACTIVATOR II - US FDA UDI
Identifiers
- Catalog Number
- 240100 FDA UDI
- Primary DI / UDI-DI
- 00810051250220 EUDAMED00859623006711 FDA UDI
- Basic UDI-DI
- 859623006a005GA EUDAMED
- Direct Marketing DI
- 00810051250220 EUDAMED
- FDA Product Code
- ORZ FDA UDI
- EMDN Code
- Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Eyelid thermal pulsation system cable/tubing FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.5200 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Pressure — 6 Pound per Square Inch FDA UDI
Category: Eyelid thermal pulsation system cable/tubing
Lipiflow System Activator Ii Cable Kit by Tearscience, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tearscience, Inc.
Sources (2)
- FDA UDI 81d13917-e6d8-48f7-9dbb-6ca6562cb7e8 37 fields · synced Jul 17, 2026
- EUDAMED 184490ba-4aba-4658-8449-acec6f2eb886 61 fields · synced Jul 17, 2026