AccessGUDID - DEVICE: AUTO REF/KERATOMETER (06971821402004)

GUDID

Device Identifier (DI) Information

Brand Name: AUTO REF/KERATOMETER
Version or Model: KR-9000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ningbo Ming Sing Optical R & D Co., Ltd.

Primary DI Number: 06971821402004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654386890 *Terms of Use

Device Description: This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. KR-9000 Auto ref/keratometer Has the functions of both refractometer and keratometer Adopts the latest ARM processor and image processing technology—fast system and more clear images Mature technique from Japan. Humanized auto mist test process: will reduce the errors caused by human eye adjustments—more accurate measure results Integral pressing and CNC machining for the optical rack: ensure the measurement consistency and accuracy—more stable system 5.7" LCD screen provides more comfortable interface Supports data transmission with auto phoropter, improving the work efficiency Auto PD measurement One-key lock function, enables to lock the moving head faster Novel design and ergonomic structure give the customer sense of beauty and comfortable operation.

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:	No
Prescription Use (Rx):	Yes
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?
36386	Automated ophthalmic refractometer	An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKO	Refractometer, Ophthalmic

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: No
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: 685f477c-bfe7-4751-a6e9-b491203b1bfe
Public Version Date: June 30, 2021
Public Version Number: 1
DI Record Publish Date: June 22, 2021