FDA UDI In Commercial Distribution 🇺🇸 United States

Clever Choice

DI: 00850002860221 · Model: BPM - 850002860221 · S.D.I. USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Clever Choice
Primary DI
00850002860221
Version / Model
BPM - 850002860221
Catalog Number
50002-0860-22
Company Name
S.D.I. USA, INC.
Labeler DUNS
116722847
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-11-30
Public Version
3
Public Version Date
2019-11-08
Public Version Status
Update
Public Device Record Key
3d26ecf7-3631-4594-81f1-58ead7d6a387

Device Description

Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Displays Blood Pressure reading as well as a World Health Organization rating of Blood Pressure readings, to easily indicate to user whether their blood pressure is too high or too low, and gives the user an idea of by how much.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No
Has Manufacturing Date
No
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
Package 10850002860228
Primary 00850002860221