N/A

GUDID 00809148082714

A hand-held battery-powered electronic instrument designed to measure a patient's body temperature using infrared waves. The device has a infrared probe and an LCD display. It is designed to take a temperature reading in approximately 1 second. This is a reusable device.

180 INNOVATIONS LLC

Infrared patient thermometer, ear
Primary Device ID00809148082714
NIH Device Record Keyc6f9011c-cb87-4034-97f2-f8d87d4b2788
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberKI-8271
Company DUNS126646582
Company Name180 INNOVATIONS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone303-271-0300
Emailinfo@180innovations.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100809148082714 [Primary]

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-16
Device Publish Date2019-04-24

On-Brand Devices [N/A]

00000000082716A hand-held battery-powered electronic instrument designed to measure a patient's body temperatu
00809148082714A hand-held battery-powered electronic instrument designed to measure a patient's body temperatu

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