GUDID 00840682110181

GE HEALTHCARE JAPAN CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00840682110181
• NIH Device Record Key: a43cc233-cbf3-4f8c-9c24-34fd3d0cc1a1
• Commercial Distribution Discontinuation: 2019-11-25
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 9L
• Company DUNS: 696021596
• Company Name: GE HEALTHCARE JAPAN CORPORATION
• Device Count: 1
• DM Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682110181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052441

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-05
• Device Publish Date: 2016-07-15

Devices Manufactured by GE HEALTHCARE JAPAN CORPORATION

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• 00195278303196 - ASiR-V: 2021-09-02 ASiR-V Application Container for Smart Subscription
• 00195278303202 - DLIR: 2021-09-02 DLIR Application Container for Smart Subscription
• 00195278303219 - MAR: 2021-09-02 MAR Application Container for Smart Subscription
• 00840682146173 - Revolution: 2020-12-04 NGX Gantry common top asm with UDI
• 00840682110181 - NA: 2020-05-05
• 00840682110181 - NA: 2020-05-05
• 00840682146586 - DLIR: 2020-03-02
• 00840682125826 - NA: 2019-12-23