Digital Expert Access

GUDID 00195278263919

DE Modality Connectivity Executable

WIPRO GE HEALTHCARE PRIVATE LIMITED

Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 00195278263919
• NIH Device Record Key: 8852431d-c1bb-443a-b6dd-145fdf329fa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Expert Access
• Version Model Number: 1
• Company DUNS: 650140403
• Company Name: WIPRO GE HEALTHCARE PRIVATE LIMITED
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00195278263919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150193

FDA Product Code

• LLZ: System, image processing, radiological

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: 2021-04-15
• Device Publish Date: 2021-04-07

Devices Manufactured by WIPRO GE HEALTHCARE PRIVATE LIMITED

• 00840682142724 - TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOX: 2022-12-14 TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOX
• 00195278263919 - Digital Expert Access: 2021-04-15DE Modality Connectivity Executable
• 00195278263919 - Digital Expert Access: 2021-04-15 DE Modality Connectivity Executable
• 00840682116992 - Mini Telemetry System: 2019-12-10
• 00840682117012 - Mini Telemetry System: 2019-12-10
• 00840682117067 - Mini Telemetry System: 2019-12-10
• 00840682117128 - Mini Telemetry System: 2019-12-10
• 00840682117166 - Mini Telemetry System: 2019-12-10
• 00840682143240 - Coro - Round MECG cable AHA: 2019-08-16