Duns Number:533186560
Device Description: QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU) is a disposable cartridge, prov QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU) is a disposable cartridge, provided sterile and ready for use. Inside the cartridge there is a tube which the fluid/blood flow through it and heated by it. While operation, the DU is connected to the Base Unit using a cable. The Disposable Unit has a standard intravenous tube extensions.
Catalog Number
QPORT1200U
Brand Name
QinFlow Blood and Fluid Warmer QiF-01 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
e5ea56f1-b3db-45ca-a3a5-b1e70845b45e
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
July 11, 2017
Package DI Number
17290016740025
Quantity per Package
10
Contains DI Package
07290016740028
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |