FDA UDI In Commercial Distribution 🇺🇸 United States

BIOS

DI: 00057475285494 · Model: 285DI · Thermor Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
BIOS
Primary DI
00057475285494
Version / Model
285DI
Company Name
Thermor Ltd
Labeler DUNS
246883458
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-05-23
Public Version
2
Public Version Date
2023-06-09
Public Version Status
Update
Public Device Record Key
ac4e58cf-54f8-40ca-b8d7-dfee526eca1b

Device Description

Non-Contact Temp Scanner

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
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
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
14035 Intermittent electronic patient thermometer

Identifiers

Type ID
Package 20057475285498
Primary 00057475285494
Package 10057475285491