Kera-Flow KF100
by Esi, Inc.
Kera-Flow KF100 is an eye-surface lavage system (FDA Class I; FDA product code KYG, Device, Irrigation, Ocular Surgery) made by Esi, Inc., listed in FDA GUDID since 10 Sep 2019 (UDI-DI B360KF100), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB360KF100 | Date10 Sep 2019 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Kera-Flow
- Generic name
- Eye-surface lavage system
- Model / Ref / Catalog
- KF100
- Primary DI / UDI-DI
- B360KF100
- FDA product code
- KYG
- GMDN term
- Eye-surface lavage system
- Device class
- Class I
- Regulation number
- 886.4360
- GUDID distribution status
- In Commercial Distribution
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