FDA UDI
In Commercial Distribution
🇺🇸 United States
BioFlo
DI: H965750320
·
Model: 75032
·
NAVILYST MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BioFlo
- Primary DI
- H965750320
- Version / Model
- 75032
- Company Name
- NAVILYST MEDICAL, INC.
- Labeler DUNS
- 809699023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-15
- Public Version
- 4
- Public Version Date
- 2021-08-16
- Public Version Status
- Update
- Public Device Record Key
- fb6c5542-9c53-4ad0-883f-23823e41d638
Device Description
BioFlo PICC with Endexo Technology - 5F x 55cm Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires)
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 |
|---|---|---|---|---|
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36257 | Peripherally-inserted central venous catheter | A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H965750325 | HIBCC | BOX | 5 | In Commercial Distribution | |
| Primary | H965750320 | HIBCC | ||||
| Secondary | 15051684026703 | GS1 |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5 | French | |
| Outer Diameter | 1.68 | Millimeter | |
| Needle Gauge | 21 | Gauge | |
| Pressure | 325 | Pound per Square Inch | |
| Length | 55 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius