DEVICE: QinFlow Warrior Extreme system (07290016740080)
Device Identifier (DI) Information
QinFlow Warrior Extreme system
QIF-01-12 kit
In Commercial Distribution
Q1210S0000U
QUALITY IN FLOW LTD
QIF-01-12 kit
In Commercial Distribution
Q1210S0000U
QUALITY IN FLOW LTD
QinFlow Warrior Extreme system kit - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body.The kit contains 1 battery. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47616 | Conduction blood/fluid warmer |
An electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.
|
Active | false |
47618 | Conduction blood/fluid warmer set |
A collection of devices 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 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LGZ | Warmer, Thermal, Infusion Fluid |
BSB | Warmer, Blood, Non-Electromagnetic Radiation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Special Storage Condition, Specify: Fragile/handle with care |
Special Storage Condition, Specify: Keep away from direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bad2e019-0de6-4dd6-be37-0bbbb131971d
March 22, 2022
2
January 24, 2019
March 22, 2022
2
January 24, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined