AccessGUDID - DEVICE: QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU) (07290016740028)

GUDID

Device Identifier (DI) Information

Brand Name: QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU)
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QPORT1200U
Company Name: QUALITY IN FLOW LTD

Primary DI Number: 07290016740028
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 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.

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:	Yes
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?
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
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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from direct sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Special Storage Condition, Specify: Fragile/handle with care

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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