FDA UDI In Commercial Distribution 🇺🇸 United States

iProvèn

DI: 08719481720780 · Model: BPM-337BT-45 · Masena Invest B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
iProvèn
Primary DI
08719481720780
Version / Model
BPM-337BT-45
Company Name
Masena Invest B.V.
Labeler DUNS
491209290
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-10-25
Public Version
3
Public Version Date
2019-11-08
Public Version Status
Update
Public Device Record Key
0b4e8c35-7bdd-4069-8ae3-646a5e2b4dd2

Device Description

Blood Pressure Monitors 45 units in one carton for measuring around the wrist with Bluetooth.

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
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
DXN System, Measurement, Blood-Pressure, Non-Invasive

GMDN Terms

Code Name
45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Identifiers

Type ID
Primary 08719481720780