BioFlo
- Primary DI
- 25051684030004
- Company
- Angiodynamics, Inc.
- Model
- H965460420
- Catalog number
- 46-042
- Device description
- BioFlo Midline with ENDEXO Technology 4F SL-10cm AST - Rapid Deployment Procedure Basic Kit
- Published
- 2025-03-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 079252781
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 25051684030004 | Package | GS1 | 5 | In Commercial Distribution |
| 15051684030007 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 25051684030004 | Package | GS1 | 5 | BX | 15051684030007 | | In Commercial Distribution |
| 15051684030007 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | General Hospital | 880.5200 | N | Ineligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Peripheral intravenous cannula | A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device. |
Device Sizes
| Type | Value | Text |
|---|
| Catheter Gauge | 4 French | |
| Length | 10 Centimeter | |
| Lumen/Inner Diameter | 0.018 Inch | |
| Outer Diameter | 1.4 Millimeter | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +1(800)772-6446 | customerservice@angiodynamics.com |
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