Bladder Scanner

GUDID 06940912714012

PBS V4.1 Bladder Scanner is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer. It is intended to project ultrasound energy through thle lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindlicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wotund and skin disease.

Mianyang Meike Electronic Equipment Co., Ltd.

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 06940912714012
• NIH Device Record Key: fce59f47-421c-490b-b06b-4d469a71d0dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bladder Scanner
• Version Model Number: PBS V4.1
• 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	06940912714012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130229

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: 6
• Public Version Date: 2019-06-19
• Device Publish Date: 2016-08-18

On-Brand Devices [Bladder Scanner]

• 06940912714012: PBS V4.1 Bladder Scanner is a medical device with high performance combined with modern B-mode u
• 06940912715019: Palm Bladder Scanner - PBSV5.1 is a medical device with high performance combined with modern B-