FDA UDI In Commercial Distribution 🇺🇸 United States

TRUE INTEGRAL

DI: 00860003079720 · Model: HTD8813C · TRUE INTEGRAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TRUE INTEGRAL
Primary DI
00860003079720
Version / Model
HTD8813C
Company Name
TRUE INTEGRAL INC
Labeler DUNS
117033737
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-12
Public Version
2
Public Version Date
2020-12-04
Public Version Status
Update
Public Device Record Key
463a818b-469b-40d3-bf52-388be6e1ded5

Device Description

No- contact infarared body thermometer

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FLL Thermometer, Electronic, Clinical

GMDN Terms

Code Name
17888 Infrared patient thermometer, skin

Identifiers

Type ID
Primary 00860003079720