Adtemp™ 424CN

GUDID 00634782564957

ADTEMP Tympanic F/C Canadian,Digital Thermometer w/covers

AMERICAN DIAGNOSTIC CORP

Infrared patient thermometer, ear
Primary Device ID00634782564957
NIH Device Record Key594d53f9-9f27-4a70-8a68-468b67fa30e2
Commercial Distribution Discontinuation2019-04-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAdtemp™
Version Model Number424CN
Catalog Number424CN
Company DUNS108999095
Company NameAMERICAN DIAGNOSTIC CORP
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

Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100634782065287 [Primary]
GS100634782564957 [Package]
Contains: 00634782864958
Package: Master Case [8 Units]
Discontinued: 2019-04-09
Not in Commercial Distribution
GS100634782864958 [Package]
Contains: 00634782065287
Package: Inner Pack [6 Units]
Discontinued: 2019-04-09
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2019-04-10
Device Publish Date2016-09-21

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00634782085186Wall Cradle, Non-Contact Therm,Acrylic w/hardware & box, RM
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00634782584375ADTMEP II, Dual Scale, Rectal,Dig Thermometer, 30s, Disp pkg
00634782584368ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30s, Disp pkg
00634782564957ADTEMP Tympanic F/C Canadian,Digital Thermometer w/covers
00634782564315ADTEMP IV Flex-tip, 10 sec,Digital Thermometer, Lrg Disp
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00634782563066ADTEMP Temple Touch,Digital Thermometer, Disp pkg
00634782563059ADTEMP Temple Touch,Digital Thermometer
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00634782554569ADTEMP VI Veterinary Therm,Dual Scale, Bulk
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00634782553463ADTEMP Digital Sheaths,50/pkg
00634782553456ADTEMP IV, SPU Dual Scale,Dig Thermometer Kit, Lrg Disp
00634782553449ADTEMP IV, Dual Scale, 10 sec,Digital Thermometer, Lrg Disp
00634782553432ADTEMP II, SPU Dual Scale, Red,Dig Therm Kit,Rectal, 30 sec
00634782553425ADTEMP II, Dual Scale, Rectal,,Dig Therm, Red, 30 sec, Bulk
00634782553418ADTEMP II, Dual Scale, Rectal,Dig Therm, Red, 30 sec
00634782553401ADTEMP II SPU, Dual Scale,Oral,Dig Therm Kit, Blue, 30 sec
00634782553395ADTEMP II,Dual Scale, Oral,Dig Therm, Blue, 30 sec, Bulk
00634782553388ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30 sec
00634782553050ADTEMP Hypothermia,Dig Therm, 10/18 sec, Bulk
00634782548391ADTEMP V Dig Therm, 8 sec,
00634782548339ADTEMP I SPU Digital,Thermometer Kit
00634782548322ADTEMP I Digital Thermometer,Bulk, no sheaths included
00634782502539ADTEMP Digital Sheaths,1000/pkg
00634782502522ADTEMP Digital Sheaths,100/pkg
00634782597443ADTEMP Mini Non-Contact Therm,w/ Lanyard
00634782899783ADTEMP Non-Contact IR Therm,
00634782899806ADTEMP Non-Contact IR Therm,
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