AccessGUDID - DEVICE: Kera-Flow (B360KF100)

GUDID

Device Identifier (DI) Information

Brand Name: Kera-Flow
Version or Model: KF100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KF100
Company Name: ESI CORPORATION

Primary DI Number: B360KF100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829391734 *Terms of Use

Device Description: Eye Irrigation Device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYG	Device, Irrigation, Ocular Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c71013c-7b01-4207-9f55-7da5e667578d
Public Version Date: September 18, 2019
Public Version Number: 1
DI Record Publish Date: September 10, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B360KF1000	1	B360KF100		In Commercial Distribution	Pouch

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES