VOLUSON

GUDID 00195278006820

VOLUSON SWIFT+ CONSOLE ASSY

GE Ultrasound Korea Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 00195278006820
• NIH Device Record Key: 4851b7cd-ed39-4d85-914c-746fb0647d8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOLUSON
• Version Model Number: SWIFT+
• Company DUNS: 690168810
• Company Name: GE Ultrasound Korea Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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

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
• 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
• 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
• 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
• 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
• 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
• 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 Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278006820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201828

FDA Product Code

• IYN: System, imaging, pulsed doppler, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-05
• Device Publish Date: 2020-10-28

On-Brand Devices [VOLUSON]

• 00840682104166: P8 BT16
• 00840682143820: S8t BT18
• 00840682138239: S10 Expert BT18
• 00840682138215: S10 BT18
• 00840682138208: P6 BT18
• 00840682138192: P8 BT18
• 00840682138185: S8 BT18
• 00840682122009: S8 BT11 to BT12 UPG
• 00840682121996: S6 BT11 to BT12 UPG
• 00840682118545: S6 BT12 to BT14 UPG
• 00840682118538: S8 BT14 to BT15 UPG
• 00840682118514: S8 BT12 to BT14 UPG
• 00840682118507: P8 BT13 to BT14 UPG
• 00840682118484: P8 BT14 to BT15 UPG
• 00840682118477: S6 BT14 to BT15 UPG
• 00840682108256: S8 Pro BT16
• 00840682104326: P6 BT16
• 00840682104319: S6 BT16
• 00840682104241: S8 BT16
• 00840682104234: S10 BT16
• 00195278006837: VOLUSON SWIFT CONSOLE ASSY
• 00195278006820: VOLUSON SWIFT+ CONSOLE ASSY
• 00195278473103: Voluson P8 BT22
• 00195278473097: Voluson P6 BT22
• 00195278473080: Voluson S6 BT22
• 00195278473073: Voluson S8 BT22
• 00195278473066: Voluson S8t BT22
• 00195278473059: Voluson S10 BT22
• 00195278473042: Voluson S10 Expert BT22
• 00195278473028: Voluson Signature to BT22 UPG
• 00195278473011: Voluson Performance to BT22 UPG
• 00195278560155: Voluson SWIFT+ BT23
• 00195278560148: Voluson SWIFT BT23
• 00195278560124: Voluson SWIFT to BT23 UPG
• 00195278633811: VOLUSON SIGNATURE 18
• 00195278633804: VOLUSON SIGNATURE 20