GUDID 00840682125420

GE Healthcare Austria GmbH & Co OG

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00840682125420
• NIH Device Record Key: 6258e528-dbec-4475-b310-bf0ae368cd2f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: C2-9-RS
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682125420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180374

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

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: 2018-04-05

Devices Manufactured by GE Healthcare Austria GmbH & Co OG

• 00195278677587 - Voluson: 2023-11-23 Voluson Exp to BT24 UPG
• 00195278699848 - Voluson: 2023-11-23 Voluson Expert 22 BT24
• 00195278699800 - Voluson: 2023-11-15 Voluson Expert 18 BT24
• 00195278699824 - Voluson: 2023-11-15 Voluson Expert 20 BT24
• 00195278283375 - RIC10-D: 2023-10-19 RIC10-D
• 00195278347473 - Voluson: 2022-08-24 Voluson Expert 18
• 00195278347480 - Voluson: 2022-08-24 Voluson Expert 20
• 00195278347497 - Voluson: 2022-06-22 Voluson Expert 22