FDA UDI In Commercial Distribution 🇺🇸 United States

TRUE METRIX

DI: 50096295139551 · Model: TRUE METRIX PRE-PACK 4x24 · TRIVIDIA HEALTH, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
TRUE METRIX
Primary DI
50096295139551
Version / Model
TRUE METRIX PRE-PACK 4x24
Catalog Number
RE4002-77
Company Name
TRIVIDIA HEALTH, INC.
Labeler DUNS
151810868
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-11
Public Version
1
Public Version Date
2020-05-19
Public Version Status
New
Public Device Record Key
29fc1ccb-158f-46bc-980e-22fd71d2afa4

Device Description

Leader TRUE METRIX PRE-PACK 4x24

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
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
NBW System, Test, Blood Glucose, Over The Counter
LFR Glucose Dehydrogenase, Glucose

GMDN Terms

Code Name
62537 Glucose monitoring system IVD, home-use

Identifiers

Type ID
Primary 50096295139551
Direct Marking 00021292007690

Customer Contacts

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
40 – 86 Degrees Fahrenheit