AccessGUDID - DEVICE: QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU) (07290016740011)

GUDID

Device Identifier (DI) Information

Brand Name: QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU)
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QPORT1100U
Company Name: QUALITY IN FLOW LTD

Primary DI Number: 07290016740011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533186560 *Terms of Use

Device Description: QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a graphic display and audio speaker for user notifications.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
BSB	Warmer, Blood, Non-Electromagnetic Radiation
LGZ	Warmer, Thermal, Infusion Fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
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
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45a2c550-e460-4db3-8e35-b37ab66f3f0b
Public Version Date: March 22, 2022
Public Version Number: 3
DI Record Publish Date: July 11, 2017