GUDID 00840682108676

GE PARALLEL DESIGN, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00840682108676
• NIH Device Record Key: 84977ad9-3a57-4900-ac01-1aef1583cfa7
• Commercial Distribution Discontinuation: 2019-12-09
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: C4-8-D
• Company DUNS: 623906971
• Company Name: GE PARALLEL DESIGN, INC.
• 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

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682108676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152567

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: 7
• Public Version Date: 2020-05-05
• Device Publish Date: 2016-07-15

Devices Manufactured by GE PARALLEL DESIGN, INC.

• 00840682142366 - NA: 2020-08-17
• 00840682108676 - NA: 2020-05-05
• 00840682108676 - NA: 2020-05-05
• 00840682113045 - NA: 2019-01-21
• 00840682105231 - NA: 2019-01-18
• 00840682105248 - NA: 2019-01-18
• 00840682105255 - NA: 2019-01-18
• 00840682115216 - NA: 2019-01-18
• 00840682105262 - NA: 2019-01-17