Hang&Go PAC R9900117

GUDID M640R99001170011

Kit for hyperthermic perfusion

RAND SPA

Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set Intravascular/intracavitary-circulation hyperthermia system set
Primary Device IDM640R99001170011
NIH Device Record Key76caf32a-331f-4888-a70d-e3104861061d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHang&Go PAC
Version Model Number001
Catalog NumberR9900117
Company DUNS655010531
Company NameRAND SPA
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]
HIBCCM640R99001170011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid
LGZWarmer, Thermal, Infusion Fluid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Hang&Go PAC]

M640R99001170001Kit for hyperthermic perfusion
M640R99001170011Kit for hyperthermic perfusion

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