Identity
- Trade Name
- Kera-Flow FDA UDI
- Generic Name
- Eye-surface lavage system FDA UDI
- Device Name
- Eye Irrigation Device FDA UDI
- Model / Reference
- KF100 FDA UDI
- Description
- Eye Irrigation Device FDA UDI
Identifiers
- Catalog Number
- KF100 FDA UDI
- Primary DI / UDI-DI
- B360KF100 FDA UDI
- FDA Product Code
- KYG FDA UDI
- GMDN Term
- Eye-surface lavage system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Eye-surface lavage system
Kera-Flow by Esi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye-surface lavage system.
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- Viscous Fluid Pack — ESCALON MEDICAL CORP · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Esi, Inc.
Sources (1)
- FDA UDI 2c71013c-7b01-4207-9f55-7da5e667578d 35 fields · synced Jun 8, 2026