FDA UDI Not in Commercial Distribution 🇺🇸 United States

iProven

DI: 00871948172070 · Model: BPM-337BT · Masena Invest B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
iProven
Primary DI
00871948172070
Version / Model
BPM-337BT
Company Name
Masena Invest B.V.
Labeler DUNS
491209290
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-05-03
Public Version
3
Public Version Date
2019-05-21
Public Version Status
Update
Public Device Record Key
caf17bc6-af37-45f6-a063-0a072411389c
Distribution End Date
2019-05-20

Device Description

Blood Pressure Monitor 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
No
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
14035 Intermittent electronic patient thermometer

Identifiers

Type ID
Primary 00871948172070