FDA UDI
In Commercial Distribution
🇺🇸 United States
QUADROX-i
DI: 04058863005805
·
Model: Small Adult, reservoir
·
Maquet Cardiopulmonary AG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QUADROX-i
- Primary DI
- 04058863005805
- Version / Model
- Small Adult, reservoir
- Catalog Number
- 70106.7967
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-15
- Public Version
- 4
- Public Version Date
- 2020-01-22
- Public Version Status
- Update
- Public Device Record Key
- a1148e6a-be3c-498d-8a72-b2624a114b66
Device Description
QUADROX-i Small Adult HMO 50000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, non-coated, vacuum-tight
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
- 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 |
|---|---|---|---|---|
| DTN | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4400 | 2 |
| DTP | Defoamer, cardiopulmonary bypass | Cardiovascular | 870.4230 | 2 |
| JOD | FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31710 | Cardiotomy reservoir | A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04058863005805 | GS1 |
Customer Contacts
- Phone
- +49072229320
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132166 | 000 |