MACHIDA

GUDID 04580137730200

MACHIDA ENDOSCOPE CO.,LTD.

Flexible fibreoptic nasopharyngoscope

• Primary Device ID: 04580137730200
• NIH Device Record Key: 7450f8a5-55fa-46db-b92c-a0f87790632b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MACHIDA
• Version Model Number: ENT-3L
• Company DUNS: 690662549
• Company Name: MACHIDA ENDOSCOPE CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580137730200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821182

FDA Product Code

• EQN: Laryngoscope, Nasopharyngoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-10

On-Brand Devices [MACHIDA]

• 04580137732518: ENT-2L
• 04580137732501: ENT-3C
• 04580137730217: ENT-4L
• 04580137730200: ENT-3L
• 04580137733041: VSP-2000
• 04580137733034: ENT-30VE
• 04580137730279: LY-CS30