Palm Bladder Scanner

GUDID 06940912716016

Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.

Mianyang Meike Electronic Equipment Co., Ltd.

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 06940912716016
• NIH Device Record Key: a06215ab-c70e-4b10-a56d-58a6fcc29fe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palm Bladder Scanner
• Version Model Number: PBSV7.1
• Company DUNS: 529177985
• Company Name: Mianyang Meike Electronic Equipment 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06940912716016 [Primary]

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, 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: 2021-06-28
• Device Publish Date: 2021-06-18

Devices Manufactured by Mianyang Meike Electronic Equipment Co., Ltd.

• 06940912716016 - Palm Bladder Scanner: 2021-06-28Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.
• 06940912716016 - Palm Bladder Scanner: 2021-06-28 Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and c
• 06940912715019 - Bladder Scanner: 2019-07-09 Palm Bladder Scanner - PBSV5.1 is a medical device with high performance combined with modern B-mode ultrasound technology and c
• 06940912714012 - Bladder Scanner: 2019-06-19 PBS V4.1 Bladder Scanner is a medical device with high performance combined with modern B-mode ultrasound technology and compute