FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.
DI: 00699753450455
·
Model: 3CX*FX15RE40
·
Terumo Cardiovascular Systems Corporation
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.
- Primary DI
- 00699753450455
- Version / Model
- 3CX*FX15RE40
- Company Name
- Terumo Cardiovascular Systems Corporation
- Labeler DUNS
- 177655466
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-01
- Public Version
- 5
- Public Version Date
- 2020-01-22
- Public Version Status
- Update
- Public Device Record Key
- d5d442c8-ada9-4053-a60c-ea3bc1425e1d
- Distribution End Date
- 2018-12-01
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 |
|---|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | Cardiovascular | 870.4350 | 2 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | Cardiovascular | 870.4400 | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | Cardiovascular | 870.4260 | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | Cardiovascular | 870.4240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17643 | Extracorporeal membrane oxygenator | A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50699753450450 | GS1 | 4 Piece Case | 4 | Not in Commercial Distribution | 2018-12-01 |
| Primary | 00699753450455 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140774 | 000 |