FDA UDI In Commercial Distribution 🇺🇸 United States

FORA

DI: 00816042013157 · Model: 6 Connect · FORA CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50

Basic Information

Brand Name
FORA
Primary DI
00816042013157
Version / Model
6 Connect
Company Name
FORA CARE INC.
Labeler DUNS
004340807
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2018-03-06
Public Version
5
Public Version Date
2023-10-18
Public Version Status
Update
Public Device Record Key
7f93d7d8-8714-488d-8fa2-e2b61b0bb412

Device Description

Ketone Test Strips

Device Characteristics

Single Use
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

GMDN Terms

Code Name
62643 Multiple clinical chemistry analyte monitoring system IVD, home-use

Identifiers

Type ID
Primary 00816042013157
Unit of Use 80816042013153