FDA UDI In Commercial Distribution 🇺🇸 United States

bt-degree

DI: 00817076010952 · Model: PG-IRT1602 · MICRO CURRENT TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
bt-degree
Primary DI
00817076010952
Version / Model
PG-IRT1602
Company Name
MICRO CURRENT TECHNOLOGY, INC.
Labeler DUNS
121167779
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-17
Public Version
2
Public Version Date
2020-12-04
Public Version Status
Update
Public Device Record Key
c2bad63c-343b-4b51-8408-7b30c19dc5c5

Device Description

IR 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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
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 00817076010952

Premarket Submissions

Submission Number Supplement Number
K182597 000