FDA UDI
In Commercial Distribution
🇺🇸 United States
QinFlow portable warmer system
DI: 17290016740032
·
Model: 01
·
QUALITY IN FLOW LTD
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QinFlow portable warmer system
- Primary DI
- 17290016740032
- Version / Model
- 01
- Catalog Number
- QPORT1000U-1
- Company Name
- QUALITY IN FLOW LTD
- Labeler DUNS
- 533186560
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-11
- Public Version
- 3
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- f003dc9f-6f17-475f-ba06-6466b8f54177
Device Description
QinFlow portable warmer system - 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 S/N of the kit is identical to the S/N of the Base Unit inside the kit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | Hematology | 864.9205 | 2 |
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17290016740032 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile/handle with care
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry