Duns Number:545188828
Device Description: MD-6000P Bladder Scanner is a hand-held ultrasonic equipment with built-in 3D mechanical s MD-6000P Bladder Scanner is a hand-held ultrasonic equipment with built-in 3D mechanical sector scan probe. It is intended to measure the urine volume in human bladder. It can be connected with Tablet PC through Wi-Fi connection for medical record data transmission and management.
Catalog Number
-
Brand Name
Bladder Scanner
Version/Model Number
MD-6000P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
0334fa9f-2c79-435b-81e3-df3a93a5983b
Public Version Date
July 09, 2019
Public Version Number
1
DI Record Publish Date
July 01, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |