HET 180-1007

GUDID 10884521511149

Temperature Monitor

Covidien LP

Electrosurgical system monitor/alarm
Primary Device ID10884521511149
NIH Device Record Key640c2beb-c2ac-424c-b4fa-8802b2bd8c3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHET
Version Model Number180-1007
Catalog Number180-1007
Company DUNS058614483
Company NameCovidien LP
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521511149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10884521511149]

Dry Heat Sterilization


[10884521511149]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-09
Device Publish Date2016-09-24

On-Brand Devices [HET]

10884521511170Reusable Cable
10884521511149Temperature Monitor
20884521511139Bipolar Forceps
10884521539792Reusable Cable For Use with HET Temperature Monitor
10884521511156Temperature Monitor
10884521791121HET Reusable Cable

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