FDA UDI
In Commercial Distribution
🇺🇸 United States
PROTEK Duo
DI: 00814112020166
·
Model: 5140-4629
·
CARDIACASSIST, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROTEK Duo
- Primary DI
- 00814112020166
- Version / Model
- 5140-4629
- Company Name
- CARDIACASSIST, INC.
- Labeler DUNS
- 948683941
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-10
- Public Version
- 4
- Public Version Date
- 2018-10-03
- Public Version Status
- Update
- Public Device Record Key
- 6b7c5b5f-18f4-4ea2-9ff6-64c17143969d
Device Description
29 Fr x 46 cm veno-venous dual lumen cannula with introducer
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
- Yes
- 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 |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 870.4210 | 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 | 00814112020166 | GS1 |
Customer Contacts
- Phone
- +14129637770
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140999 | 000 |