FDA UDI In Commercial Distribution 🇺🇸 United States

Areta 10 Parameters Urinalysis Reagent Strips (50 tests kit)

DI: 00850253007048 · Model: U031-103 · EASY HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Areta 10 Parameters Urinalysis Reagent Strips (50 tests kit)
Primary DI
00850253007048
Version / Model
U031-103
Company Name
EASY HEALTHCARE CORPORATION
Labeler DUNS
080278407
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-05
Public Version
4
Public Version Date
2019-07-22
Public Version Status
Update
Public Device Record Key
050f7cc9-8c50-422c-956b-4d870808f8e3

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

GMDN Terms

Code Name
30219 Multiple urine analyte IVD, control

Identifiers

Type ID
Primary 00850253007048
Package 00850253007055
Package 10850253007052