MACHIDA

Basic Information

• Brand Name: MACHIDA
• Primary DI: 04580137733041
• Version / Model: VSP-2000
• Company Name: MACHIDA ENDOSCOPE CO.,LTD.
• Labeler DUNS: 690662549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-08
• Public Version: 1
• Public Version Date: 2022-08-16
• Public Version Status: New
• Public Device Record Key: 3383b985-07fd-44ee-9412-45dd1a5bda9e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• 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
EQN	Laryngoscope, Nasopharyngoscope	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47140	Endoscopic control/video-imaging system	A mains electricity (AC-powered) multifunctional device assembly designed to interface with a flexible steerable, self-propelled, or externally-propelled video endoscope (not included) to: 1) control movement of the endoscope (e.g., steer, propel); and 2) receive and process electronic video image signals sent from the endoscope. It includes a controller/control unit, image processor, and may include an image display monitor and light source. It might additionally allow control of insufflation or suction.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04580137733041	GS1

Premarket Submissions

Submission Number	Supplement Number
K821182	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius