FDA UDI
In Commercial Distribution
🇺🇸 United States
MC3 Crescent RA Dual Lumen Catheter 15FR
DI: 10850007732216
·
Model: 70415
·
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MC3 Crescent RA Dual Lumen Catheter 15FR
- Primary DI
- 10850007732216
- Version / Model
- 70415
- Catalog Number
- 70415
- 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
- 2021-09-01
- Public Version
- 1
- Public Version Date
- 2021-09-09
- Public Version Status
- New
- Public Device Record Key
- 0a239010-1d2a-49bf-b87c-251ab9f95660
Device Description
The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
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 |
|---|---|---|---|---|
| PZS | Dual Lumen Ecmo Cannula | Cardiovascular | 870.4100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58726 | Mobile extracorporeal gas exchange system catheter kit | A collection of sterile devices that is a component of a mobile extracorporeal gas exchange system and which includes a dedicated dual-lumen venous catheter. The catheter is designed to conduct blood from the patient and return it to the venous system (veno-venous) after extracorporeal circulation and gas exchange; it is intended for use with femoral or jugular veins and is designed for low-resistance to flow while also resisting kinks. In addition to the catheter, the kit typically includes a syringe, needles, guidewires, a scalpel, and dilators. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850007732216 | GS1 |