CFM Technologies

Basic Information

• Brand Name: CFM Technologies
• Primary DI: 00850013958146
• Version / Model: ENT-DFK
• Catalog Number: ENT-DFK
• Company Name: C F M TECHNOLOGIES INC
• Labeler DUNS: 040748944
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-06
• Public Version: 4
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 8cb3778a-5541-4bdc-8594-89c5060b9274

Device Description

Deluxe ENT Field Kit. This kit contains a versatile set of components designed to facilitate effective examination of the eyes, ears, nose and throat.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HPN	Magnet, Permanent	Ophthalmic	886.4445	1
JYG	Curette, Ear	Ear, Nose, Throat	874.4420	1
ERA	Otoscope	Ear, Nose, Throat	874.4770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46786	Direct ophthalmoscope	An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.	No	Active
33737	Corneal staining strip	A small absorbent strip, made of filter paper or similar material, which is impregnated with a small amount of a chemical (e.g., fluorescein sodium, lissamine green) intended to be applied to the cornea to function as a dye for ophthalmic examinations of the anterior segment of the eye. It is typically used to stain the cornea when fitting contact lenses, to disclose corneal injury (e.g., to enhance superficial abrasions for examination), in applanation tonometry, or evaluation of dry eye syndrome. This is a single-use device.	No	Active
46718	Eye magnet, non-powered	A non-electric hand-held instrument designed to generate a magnetic field intended to locate and remove metallic foreign bodies [typically those containing iron (Fe) or steel] from eye tissue; it may include a wire loop at one end for mechanical extraction. This is a reusable device.	No	Active
34897	Ear speculum, single-use	A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.	No	Active
33395	Ear speculum, reusable	A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.	No	Active
12849	Otoscope, direct	An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.	No	Active
45084	Ophthalmic/otologic diagnostic set	A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013958146	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]