FDA.reportPublic FDA data

QinFlow Blood and Fluid Warmer QiF-01 Disposable U

Primary DI
17290016740025
Brand
QinFlow Blood and Fluid Warmer QiF-01 Disposable U
Company
QUALITY IN FLOW LTD
Model
01
Catalog number
QPORT1200U
Device description
QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU) is a disposable cartridge, provided sterile and ready for use. Inside the cartridge there i
Published
2017-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSBWarmer, Blood, Non-Electromagnetic Radiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSBWarmer, Blood, Non-Electromagnetic RadiationHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016740025PackageGS110In Commercial Distribution
07290016740028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001674002517290016740025
07290016740028072900167400287290016740028

GMDN Terms#

Term, Definition table
TermDefinition
Conduction blood/fluid warmer setA sterile device(s) used in conjunction with a conduction blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It typically consists of a pouch(es) or a flexible cassette through which blood/fluid flows from the infusion bag to the patient while being heated in-line by the warmer; clamps and a bubble trap may be included. The set is typically used in the operating room (OR) or in accident and emergency (A&E) situations when rapid infusion of several units of blood/fluid is necessary. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile/handle with care
Special Storage Condition, Specify00Keep away from direct sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533186560
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016740202Warrior AC StationQIF-01-122025-02-18
17290016740209QINFLOW AC STATION INTRO SET EXTREMEQIF-01-122025-02-18
27290016740206QINFLOW AC STATION EXTENDED SET EXTREMEQIF-01-122025-02-18
37290016740166QINFLOW WARRIOR LITE SET WITH LITE BATTERYQIF-032025-02-18
37290016740203QINFLOW AC STATION INTRO SET WARRIORQIF-01-12W2025-02-18
47290016740163QINFLOW WARRIOR LITE SET WITH 2 LITE BATTERYQIF-032025-02-18
47290016740200QINFLOW AC STATION EXTENDED SET WARRIORQIF-01-12W2025-02-18
07290016740110Rechargeable Lite BatteryQIF-03QIF03-BTA10002023-01-04
07290016740158Rechargeable Lite Extra Power BatteryQIF-03QIF03-BTA20002023-01-04
07290016740066QinFlow Enhanced Battery01QPORT1180U2019-01-24
17290016740162QinFlow Warrior Lite set with 1 Lite Extra Power BatteryQIF-032023-01-05
27290016740169QinFlow Warrior Lite set with 2 Lite Extra Power BatteryQIF-032023-01-05
07290016740042AC Power supply ModuleQACPLUS10002023-01-04
07290016740097QIF-01-12 extended kit QIF-01-12Q1220S1000U2023-01-04
07290016740103Warrior Lite Blood and Fluid Warmer Base UnitQIF-03QIF03-BUA10002023-01-04
07290016740134Warrior pole mounting012023-01-04
17290016740049QINFLOW WARRIOR HYBRID INTRO SET 012023-01-04
27290016740039QIF-01 extended kit 01Q1120S1000U2023-01-04
27290016740046QINFLOW WARRIOR HYBRID EXTENDED SET 012023-01-04
07290016740028QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU)01QPORT1200U2017-07-11

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