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BioFlo 75012

by Navilyst Medical, Inc.

BioFlo 75012 is a Class II device made by Navilyst Medical, Inc., listed in FDA GUDID since 15 Sep 2015 (UDI-DI H965750120), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberH965750120 UDI-DI Date15 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
BioFlo
Generic name
Peripherally-inserted central venous catheter
Model / reference
75012
Primary DI / UDI-DI
H965750120
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
Pressure — 325 Pound per Square Inch
Outer Diameter — 1.4 Millimeter
Length — 55 Centimeter
Catheter Gauge — 4 French
Needle Gauge — 21 Gauge

Similar devices

Other devices filed under FDA product code LJS (Catheter,intravascular,therapeutic,long-term greater than 30 days).

Other devices from Navilyst Medical, Inc.

See all devices from Navilyst Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)