FDA UDI In Commercial Distribution 🇺🇸 United States

TRUE METRIX

DI: 00021292007829 · Model: TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 25 Test Strips · TRIVIDIA HEALTH, INC.
Product Codes
2
GMDN Terms
1
Identifiers
18
Pkg Device Count
25

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Basic Information

Brand Name
TRUE METRIX
Primary DI
00021292007829
Version / Model
TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 25 Test Strips
Company Name
TRIVIDIA HEALTH, INC.
Labeler DUNS
151810868
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2016-09-20
Public Version
4
Public Version Date
2020-03-10
Public Version Status
Update
Public Device Record Key
c556653e-e3d2-4083-ae03-9b0a1c6839d0

Device Description

TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 25 Test Strips

Device Characteristics

Single Use
Yes
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
LFR Glucose Dehydrogenase, Glucose
NBW System, Test, Blood Glucose, Over The Counter

GMDN Terms

Code Name
62537 Glucose monitoring system IVD, home-use

Identifiers

Type ID
Primary 00021292007829
Unit of Use 00021292007799
Package 00021292006174
Package 10311917173884
Package 00311917173887
Package 10087701426725
Package 00087701426728
Package 10021292007406
Package 00021292007409
Package 10041220001290
Package 00041220001293
Package 10021292006171
Package 00041415069787
Package 10041415069784
Package 00725439988940
Package 10725439988947
Package 00050428558348
Package 10050428558345

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
40 – 86 Degrees Fahrenheit