Symmetrical Health, LLC

GUDID 08809462732205

CIMILRE CO .,LTD

Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric
Primary Device ID08809462732205
NIH Device Record Key4fda0fa9-e9ee-47eb-8ff4-64f22bb38264
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymmetrical Health, LLC
Version Model NumberCimilre S6 plus
Company DUNS689851831
Company NameCIMILRE CO .,LTD
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com
Phone888-394-2422
Emailhelp@cimilrebreastpumps.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]
GS108809462732205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered
HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-15
Device Publish Date2020-09-07

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