FDA UDI
In Commercial Distribution
🇺🇸 United States
QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU)
DI: 07290016740011
·
Model: 01
·
QUALITY IN FLOW LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU)
- Primary DI
- 07290016740011
- Version / Model
- 01
- Catalog Number
- QPORT1100U
- 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
- 45a2c550-e460-4db3-8e35-b37ab66f3f0b
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| 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 | 07290016740011 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile/handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry