Kera-Flow KF100

GUDID B360KF100

Eye Irrigation Device

ESI CORPORATION

Eye-surface lavage system

• Primary Device ID: B360KF100
• NIH Device Record Key: 2c71013c-7b01-4207-9f55-7da5e667578d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kera-Flow
• Version Model Number: KF100
• Catalog Number: KF100
• Company DUNS: 829391734
• Company Name: ESI CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 763-473-2533
• Email: sales@eyesurgin.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B360KF100 [Primary]
HIBCC	B360KF1000 [Package]; Package: Pouch [1 Units]; In Commercial Distribution

FDA Product Code

• KYG: Device, Irrigation, Ocular Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-09-10

Devices Manufactured by ESI CORPORATION

• B360PSVGS0 - PRAGER SHELL® P106SVGS: 2019-12-26 PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.
• B360011B12361 - Prager Ext Set A1236: 2019-12-11 Replacement Part
• B360011B12632 - Prager Ext Set B1263: 2019-12-11 Replacement Part
• B360KF100 - Kera-Flow: 2019-09-18Eye Irrigation Device
• B360KF100 - Kera-Flow: 2019-09-18 Eye Irrigation Device
• B360CS2001 - ClearScan®: 2018-07-06 ClearScan
• B360P1000 - Prager Shell®: 2018-07-06 Accutome / MicroMedical
• B360P100AS0 - Prager Shell®: 2018-07-06 Accutome Probe, Auto Stop
• B360P1010 - Prager Shell®: 2018-07-06 For DGH 2009 and earlier