186-0150-PH

GUDID 10884521134324

Sensor Quatro Start-Up Kit

Covidien LP

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID10884521134324
NIH Device Record Key6a5ddc97-131e-4182-bf5d-772bba2fad13
Commercial Distribution StatusIn Commercial Distribution
Version Model Number186-0150-PH
Catalog Number186-0150-PH
Company DUNS058614483
Company NameCovidien LP
Device Count5
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 Datetrue
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
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile; Keep dry; This side up;
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521134324 [Primary]
GS120884521134321 [Unit of Use]
GS120884521657820 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYELECTRODE, CUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2016-10-13

Devices Manufactured by Covidien LP

20884521033129 - Valleylab2025-03-24 Laparoscopic Handset Four-Function Non-Sterile Bulk;Caution: For manufacturing, processing, or repacking
30884522020279 - DAR2025-03-18 Catheter Mount
10884522034753 - DAR2025-03-18 Catheter Mount Extendable
10884522034791 - DAR2025-03-18 Catheter Mount Extendable
20884521066172 - DAR2025-03-17 Catheter Mount Extendable
10884521528086 - DAR2025-03-17 Catheter Mount
20884522020081 - DAR2025-03-17 Catheter Mount
30884522020118 - DAR2025-03-17 Catheter Mount

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