FDA UDI In Commercial Distribution 🇺🇸 United States

TDNexLabs

DI: 03770027519003 · Model: TDNexLabs · TECHNIDATA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TDNexLabs
Primary DI
03770027519003
Version / Model
TDNexLabs
Company Name
TECHNIDATA
Labeler DUNS
383120136
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-08
Public Version
1
Public Version Date
2022-08-16
Public Version Status
New
Public Device Record Key
4275977d-9681-48eb-ba1b-f62ebf9eab80

Device Description

TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used for the management of clinical information. TDNexLabs is intended to be used only by health professionals.

Device Characteristics

Single Use
No
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JQP Calculator/Data Processing Module, For Clinical Use

GMDN Terms

Code Name
44082 Clinical laboratory information system application software

Identifiers

Type ID
Primary 03770027519003