FDA UDI
In Commercial Distribution
🇺🇸 United States
Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W
DI: 18051160302205
·
Model: HX55V-S0W
·
SPECTRUM MEDICAL SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W
- Primary DI
- 18051160302205
- Version / Model
- HX55V-S0W
- Company Name
- SPECTRUM MEDICAL SRL
- Labeler DUNS
- 436188505
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-19
- Public Version
- 1
- Public Version Date
- 2024-11-27
- Public Version Status
- New
- Public Device Record Key
- a8fd7e3b-7af6-46ff-9963-f45a1cadd73f
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | Cardiovascular | 870.4240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64585 | Cardiopulmonary bypass system heat exchanger, single-use | A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18051160302205 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223879 | 000 |