Voluson

GUDID 00195278016812

GE Healthcare Austria GmbH & Co OG

General-purpose ultrasound imaging system

• Primary Device ID: 00195278016812
• NIH Device Record Key: d79828e3-c95f-4e36-9b4b-4e182923d450
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Voluson
• Version Model Number: E10 BT21
• Company DUNS: 300599979
• Company Name: GE Healthcare Austria GmbH & Co OG
• 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
• 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

• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278016812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192159

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: 2020-09-29
• Device Publish Date: 2020-09-21

On-Brand Devices [Voluson]

• 00840682145411: E BT19 to BT20 UPG
• 00840682144353: E10 BT20
• 00840682144346: VE8 BT20
• 00840682144339: E6 BT20
• 00840682142588: E BT17 to BT19 UPG
• 00840682139533: E BT18 to BT19 UPG
• 00840682139168: VE8 BT19
• 00840682139151: E10 BT19
• 00840682139144: E6 BT19
• 00840682123945: E8 BT18
• 00840682123938: E10 BT18
• 00840682123907: E6 BT18
• 00840682123891: E BT17 to BT18 UPG
• 00840682120661: E BT16 to BT17 UPG
• 00840682120197: E BT15 to BT17 UPG
• 00840682119672: ie all BTs to BT14 UPG
• 00840682118712: E BT10 to BT13 UPG
• 00840682118705: E BT15 to BT16 UPG
• 00840682118675: E BT12 to BT13 UPG
• 00840682117951: E10 BT17
• 00840682117944: E8 BT17
• 00840682117937: E6 BT17
• 00840682100144: E10 BT16
• 00840682100137: E8 BT16
• 00840682100120: E6 BT16
• 00195278077592: E BT20 to BT21 UPG
• 00195278016836: E6 BT21
• 00195278016829: E8 BT21
• 00195278016812: E10 BT21
• 00195278347497: Voluson Expert 22
• 00195278347480: Voluson Expert 20
• 00195278347473: Voluson Expert 18
• 00195278699824: Voluson Expert 20 BT24
• 00195278699800: Voluson Expert 18 BT24
• 00195278699848: Voluson Expert 22 BT24
• 00195278677587: Voluson Exp to BT24 UPG