FDA UDI In Commercial Distribution 🇺🇸 United States

Clever Choice

DI: 00898302140216 · Model: Voice HD Meter · SIMPLE DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Clever Choice
Primary DI
00898302140216
Version / Model
Voice HD Meter
Catalog Number
98302-0001-29
Company Name
SIMPLE DIAGNOSTICS INC
Labeler DUNS
004135503
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-01
Public Version
3
Public Version Date
2019-08-30
Public Version Status
Update
Public Device Record Key
e61db798-972c-4d1a-9329-7b3859dc5cab

Device Description

Clever Choice Voice HD Blood Glucose meter. Uses HD Test Strips. Ideal for Diabetics. Speaks to help vision impaired.

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
Yes
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
NBW System, Test, Blood Glucose, Over The Counter

GMDN Terms

Code Name
62537 Glucose monitoring system IVD, home-use

Identifiers

Type ID
Package 10898302140213
Primary 00898302140216