BioFlo 75-053
BioFlo 75-053 is a Class II device made by Navilyst Medical, Inc., listed in FDA GUDID since 3 Jun 2019 (UDI-DI H965750530), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberH965750530 | Date3 Jun 2019 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- BioFlo
- Generic name
- Peripherally-inserted central venous catheter
- Model / reference
- 75-053
- Primary DI / UDI-DI
- H965750530
- FDA product code
- LJS
- GMDN term
- Peripherally-inserted central venous catheter
- Device class
- Class II
- Regulation number
- 880.5970
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 6 FrenchLength — 55 CentimeterNeedle Gauge — 21 GaugeOuter Diameter — 2.2 MillimeterPressure — 268 Pound per Square Inch
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