FDA UDI In Commercial Distribution 🇺🇸 United States

Flowtaker Disposable Home Uroflowmeters, set of 10

DI: 08717775956143 · Model: U10-1 · Medical Measurement Systems B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
Flowtaker Disposable Home Uroflowmeters, set of 10
Primary DI
08717775956143
Version / Model
U10-1
Company Name
Medical Measurement Systems B.V.
Labeler DUNS
416277333
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2016-09-23
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
f4f10223-89e2-4262-9ab9-b734328c8e97

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FEN DEVICE, CYSTOMETRIC, HYDRAULIC

GMDN Terms

Code Name
14307 Urodynamic measurement system

Identifiers

Type ID
Primary 08717775956143
Unit of Use 08717775956136