QinFlow Warrior Extreme system - QinFlow Warrior Extreme system kit - the QiF - QUALITY IN FLOW LTD

Duns Number:533186560

Device Description: QinFlow Warrior Extreme system kit - the QiF warmer is a portable, inline blood and fluid 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.

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More Product Details

Catalog Number

Q1210S0000U

Brand Name

QinFlow Warrior Extreme system

Version/Model Number

QIF-01-12 kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BSB

Product Code Name

Warmer, Blood, Non-Electromagnetic Radiation

Device Record Status

Public Device Record Key

bad2e019-0de6-4dd6-be37-0bbbb131971d

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

January 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUALITY IN FLOW LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7