FDA UDI In Commercial Distribution 🇺🇸 United States

Bladder Scanner

DI: 06948941160008 · Model: MD-6000 · Meda Co., Ltd
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Bladder Scanner
Primary DI
06948941160008
Version / Model
MD-6000
Company Name
Meda Co., Ltd
Labeler DUNS
545188828
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-01
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
66efd1e7-27ed-42b4-825d-9bbc0443d987

Device Description

MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It utilizes ultrasonic distance measuring principle to measure the volume of bladder filled with urine.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IYO System, Imaging, Pulsed Echo, Ultrasonic
ITX Transducer, Ultrasonic, Diagnostic

GMDN Terms

Code Name
41501 Bladder volume ultrasound imaging system

Identifiers

Type ID
Primary 06948941160008