QinFlow Blood and Fluid Warmer QiF-01 Base Unit (B QPORT1100U

GUDID 07290016740011

QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains

QUALITY IN FLOW LTD

Conduction blood/fluid warmer
Primary Device ID07290016740011
NIH Device Record Key45a2c550-e460-4db3-8e35-b37ab66f3f0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameQinFlow Blood and Fluid Warmer QiF-01 Base Unit (B
Version Model Number01
Catalog NumberQPORT1100U
Company DUNS533186560
Company NameQUALITY IN FLOW LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile/handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016740011 [Primary]

FDA Product Code

BSBWarmer, Blood, Non-Electromagnetic Radiation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-11

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