FDA UDI In Commercial Distribution 🇺🇸 United States

EQUALINE

DI: 00041163495777 · Model: KD-181 · SUPERVALU INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
EQUALINE
Primary DI
00041163495777
Version / Model
KD-181
Company Name
SUPERVALU INC.
Labeler DUNS
006961411
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
873717ae-6651-40e3-8e35-868d6dc5b118

Device Description

A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to to measure a patient's body temperature. The device has a flexible tip and an LCD display. It is designed to take a temperature reading in approximately 30 seconds. This is a reusable device.

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 40041163495775
Package 20041163495771
Primary 00041163495777