FDA UDI
In Commercial Distribution
🇺🇸 United States
MC3 Nautilus ECMO Oxygenator
DI: 10854916006901
·
Model: 48145E
·
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MC3 Nautilus ECMO Oxygenator
- Primary DI
- 10854916006901
- Version / Model
- 48145E
- Catalog Number
- 48145E
- Company Name
- MICHIGAN CRITICAL CARE CONSULTANTS, INC.
- Labeler DUNS
- 806687406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-03
- Public Version
- 1
- Public Version Date
- 2023-07-11
- Public Version Status
- New
- Public Device Record Key
- cadd0bdd-4770-4ac5-a7ac-736af2109633
Device Description
Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed.
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
- Yes
- 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 |
|---|---|---|---|---|
| BYS | Oxygenator, Long Term Support Greater Than 6 Hours | Cardiovascular | 870.4100 | 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 | 20854916006908 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 10854916006901 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191935 | 000 |