JEDMED

Basic Information

• Brand Name: JEDMED
• Primary DI: M6330415400
• Version / Model: 04-1540
• Catalog Number: 04-1540
• Company Name: JEDMED INSTRUMENT COMPANY
• Labeler DUNS: 092987189
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-17
• Public Version: 1
• Public Version Date: 2018-08-17
• Public Version Status: New
• Public Device Record Key: 4c8eef61-a733-443a-9846-e4775af23ec8

Device Description

"S-II" Chair Manual Base

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: Yes
• 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
FRK	Chair, Examination And Treatment	General Hospital	880.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47147	ENT chair, mechanical	A manually- or hydraulically-powered device designed to support a patient in a seated position to facilitate ear, nose, throat (i.e., ENT) examination, treatment, and/or minor surgery. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to standard positions. Devices intended for ENT examination and/or treatment (e.g., otoscopes, laryngoscopes) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M6330415400	HIBCC

Customer Contacts

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