FDA UDI
In Commercial Distribution
🇺🇸 United States
Kera-Flow
DI: B360KF100
·
Model: KF100
·
ESI CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Kera-Flow
- Primary DI
- B360KF100
- Version / Model
- KF100
- Catalog Number
- KF100
- Company Name
- ESI CORPORATION
- Labeler DUNS
- 829391734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-10
- Public Version
- 1
- Public Version Date
- 2019-09-18
- Public Version Status
- New
- Public Device Record Key
- 2c71013c-7b01-4207-9f55-7da5e667578d
Device Description
Eye Irrigation Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | 886.4360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35151 | Eye-surface lavage system | A device assembly designed for automated or semi-automated irrigation and washing of the eye surface (i.e., sclera and cornea). It typically consists of a main electromechanical unit that may include a pump for infusion of non-medicated liquid (e.g., saline), an extractor, and controls for the temperature and the rate of irrigation; it may be coupled to special lenses (e.g., Morgan therapeutic) and/or to dedicated handpieces (e.g., Lewis), cannulae, catheters, and/or probes. The system is used to remove damaged tissue and/or debris (e.g., foreign objects) for ophthalmic procedures/surgery and in emergency departments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B360KF100 | HIBCC | ||||
| Package | B360KF1000 | HIBCC | Pouch | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 763-473-2533
- [email protected]