N/A H48062AN

GUDID 00195278644152

RAB7-D

GE Medical Systems (China) Co.,Ltd.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00195278644152
• NIH Device Record Key: f2bf4118-3cd6-45f5-a796-a57292cdbe05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: RAB7-D
• Catalog Number: H48062AN
• Company DUNS: 654658731
• Company Name: GE Medical Systems (China) Co.,Ltd.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278644152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242168

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2025-01-17
• Device Publish Date: 2025-01-09

Devices Manufactured by GE Medical Systems (China) Co.,Ltd.

• 00195278644152 - N/A: 2025-01-17RAB7-D
• 00195278644152 - N/A: 2025-01-17 RAB7-D
• 00195278690401 - Versana: 2024-11-28 Magna R3 LOTUS 4pp Basic console
• 00195278690418 - Versana: 2024-11-28 Magna R3 LOTUS 5pp Basic console
• 00195278722430 - LOGIQ: 2024-11-28 Magna R3 LOGIQ F Basic console
• 00195278690388 - Versana: 2024-11-05 Magna R3 VS Basic console
• 00195278690395 - Versana: 2024-11-05 Magna R3 VA Basic console
• 00195278466471 - NA: 2024-06-07 L4-20t-D
• 00195278674197 - LOGIQ: 2023-12-28 LOGIQ e TP Standard Console