FDA UDI
In Commercial Distribution
🇺🇸 United States
MC3 Crescent(tm) Jugular Dual Lumen Catheter
DI: 10854916006925
·
Model: 70126
·
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MC3 Crescent(tm) Jugular Dual Lumen Catheter
- Primary DI
- 10854916006925
- Version / Model
- 70126
- Catalog Number
- 70126
- 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
- 2019-06-03
- Public Version
- 2
- Public Version Date
- 2019-06-13
- Public Version Status
- Update
- Public Device Record Key
- cf222af9-004d-45af-8089-6b78905b3e12
Device Description
Jugular Dual Lumen Catheter 26 Fr
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Previous | 10854916006796 | GS1 | ||||
| Primary | 10854916006925 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 26 | French |