FDA UDI
In Commercial Distribution
🇺🇸 United States
QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU)
DI: 07290016740028
·
Model: 01
·
QUALITY IN FLOW LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU)
- Primary DI
- 07290016740028
- Version / Model
- 01
- Catalog Number
- QPORT1200U
- 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
- 4
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- e5ea56f1-b3db-45ca-a3a5-b1e70845b45e
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
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290016740025 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 07290016740028 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile/handle with care