Duns Number:533186560
Device Description: QinFlow Blood and Fluid Warmer QiF-01 Compact Disposable Unit (CDU) is a disposable cartri QinFlow Blood and Fluid Warmer QiF-01 Compact Disposable Unit (CDU) is a disposable cartridge, provided sterile and ready for use. Inside thecartridge there is a tube which the fluid/blood flow through it and heated by it. While operation, the CDU is connected to theBase Unit using a cable. The Compact Disposable Unit has a standard intravenous tube extensions.
Catalog Number
QPORT0500U
Brand Name
QinFlow Blood and Fluid Warmer QiF-01 Compact Disposable Unit (DU)
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
Yes
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
BSB
Product Code Name
Warmer, Blood, Non-Electromagnetic Radiation
Public Device Record Key
2d187916-b3cb-4952-b74b-96eb915b1da4
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
February 16, 2018
Package DI Number
17290016740056
Quantity per Package
10
Contains DI Package
37290016740050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |