Falck Medical Multi-Function Applanation Tonometer

Basic Information

• Brand Name: Falck Medical Multi-Function Applanation Tonometer
• Primary DI: 00867009000208
• Version / Model: FMAT1
• Company Name: FALCK MEDICAL INC
• Labeler DUNS: 010283033
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ff71fa08-5a8a-45e7-b27f-eb4a46767852

Device Description

Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry and Tonography Measurement

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKY	Tonometer, Manual	Ophthalmic	886.1930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35399	Ophthalmic tonometer, line-powered	An ophthalmic, line-powered, measuring instrument used for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00867009000208	GS1

Device Sizes

Type	Value	Unit	Text
Width	15	Centimeter
Length	20	Centimeter
Depth	5	Centimeter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 55 Degrees Celsius