FDA UDI
In Commercial Distribution
🇺🇸 United States
BioFlo
DI: H965103029010
·
Model: 02-901
·
NAVILYST MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BioFlo
- Primary DI
- H965103029010
- Version / Model
- 02-901
- Company Name
- NAVILYST MEDICAL, INC.
- Labeler DUNS
- 809699023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-17
- Public Version
- 4
- Public Version Date
- 2021-05-05
- Public Version Status
- Update
- Public Device Record Key
- 9b74301c-7c46-49cb-aeb2-8f35e3dcfe1b
Device Description
15.5Fx20cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Kit
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 |
|---|---|---|---|---|
| MSD | Catheter, hemodialysis, implanted | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37278 | Double-lumen haemodialysis catheter, implantable | An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H965103029011 | HIBCC | BOX | 5 | In Commercial Distribution | |
| Primary | H965103029010 | HIBCC | ||||
| Secondary | 15051684025751 | GS1 |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 15.5 | French | |
| Length | 20 | Centimeter | |
| Outer Diameter | 5.2 | Millimeter |