UNIVERSAL BLUE™ RF Sensor ICM-000-0599

GUDID 00817688020363

UNIVERSAL BLUE™ RF Sensor

I.C. MEDICAL, INC.

Surgical plume evacuation system
Primary Device ID00817688020363
NIH Device Record Keya440e2fc-2dd3-42b0-a78e-740927d51a4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIVERSAL BLUE™ RF Sensor
Version Model NumberICM-000-0599
Catalog NumberICM-000-0599
Company DUNS616182895
Company NameI.C. MEDICAL, INC.
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

Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100817688020363 [Primary]

FDA Product Code

FYDApparatus, Exhaust, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-26
Device Publish Date2020-10-16

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