FDA UDI In Commercial Distribution 🇺🇸 United States

HOMEDICS

DI: 00031262098986 · Model: TIE-240 · FKA DISTRIBUTING CO., LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1

Basic Information

Brand Name
HOMEDICS
Primary DI
00031262098986
Version / Model
TIE-240
Company Name
FKA DISTRIBUTING CO., LLC
Labeler DUNS
183280973
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-05
Public Version
3
Public Version Date
2021-01-21
Public Version Status
Update
Public Device Record Key
12914550-6776-45e9-805d-13029fb6de8a

Device Description

Non-contact Infrared Body Thermometer

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
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
FLL Thermometer, Electronic, Clinical

GMDN Terms

Code Name
17888 Infrared patient thermometer, skin

Identifiers

Type ID
Primary 00031262098986
Package 10031262098983
Package 20031262098980
Package 50031262098981