FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDIOTOMY RESERVOIR
DI: 08033178250375
·
Model: FILTERED
·
SORIN GROUP ITALIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CARDIOTOMY RESERVOIR
- Primary DI
- 08033178250375
- Version / Model
- FILTERED
- Company Name
- SORIN GROUP ITALIA SRL
- Labeler DUNS
- 442126587
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-15
- Public Version
- 4
- Public Version Date
- 2020-01-22
- Public Version Status
- Update
- Public Device Record Key
- 391509d7-3103-4561-81a9-e22f0cfb3fc4
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
- 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 |
|---|---|---|---|---|
| DTP | Defoamer, cardiopulmonary bypass | Cardiovascular | 870.4230 | 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 |
|---|---|---|---|---|---|---|
| Package | 38033178250376 | GS1 | BOX | 6 | In Commercial Distribution | |
| Primary | 08033178250375 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K902437 | 000 |