FDA UDI In Commercial Distribution 🇺🇸 United States

ARC InstaTemp Infrared Thermometer

DI: 00853524006023 · Model: 602 · ARC DEVICES USA INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ARC InstaTemp Infrared Thermometer
Primary DI
00853524006023
Version / Model
602
Company Name
ARC DEVICES USA INC
Labeler DUNS
079758824
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-03-30
Public Version
3
Public Version Date
2020-12-04
Public Version Status
Update
Public Device Record Key
85c838d6-9eb0-4d61-b98a-a92693db1c71

Device Description

InstaTemp Digital Non-Touch Infrared Thermometer intended to be used to measure temperature in infants and adults This device can be used in the home or in a clinical setting.

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 00853524006023