BioFlo

GUDID H965750500

BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit.

NAVILYST MEDICAL, INC.

Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter
Primary Device IDH965750500
NIH Device Record Key4b24d33e-22ef-4cbb-aa0b-89e6e40d7983
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioFlo
Version Model Number75-050
Company DUNS809699023
Company NameNAVILYST MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com

Device Dimensions

Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French
Needle Gauge21 Gauge
Pressure214 Pound per Square Inch
Outer Diameter1.75 Millimeter
Length55 Centimeter
Catheter Gauge5 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115051684026420 [Secondary]
HIBCCH965750500 [Primary]
HIBCCH965750501 [Package]
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJSCatheter, intravascular, therapeutic, long-term greater than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-11
Device Publish Date2019-06-03

On-Brand Devices [BioFlo]

H965PKM61058234S1PICC Convenience Kit
H96560M1303191PICC Convenience Kit
H96560M1303171PICC Convenience Kit
H96560M1303151PICC Convenience Kit
H96560M13031101PICC Convenience Kit
H965PKM220851S1PICC Convenience Kit
H965PKM1300011S1PICC Convenience Kit
H96560M0134211PICC Convenience Kit
H965PKM194923S1PICC Convenience Kit
H965PKM131934S1PICC Convenience Kit
H965PKM61102513S1PICC Convenience Kit
H965PKM61102512S1PICC Convenience Kit
H965PKM130343S1PICC Convenience Kit
H965750670BioFlo PICC with ENDEXO Technology (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated
H965750660BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Bar
H965750650BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Du
H965750640BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual
H965750630BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Single Lumen) - Maximal Barrier Du
H965750620BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Single Lumen) - Maximal Barrier Du
H965750610BioFlo PICC with ENDEXO and PASV Valve Technology (4F x 55cm, Single Lumen) - Maximal Barrier Du
H965750600BioFlo PICC with ENDEXO Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Dual Fenestrated
H965750590BioFlo PICC with ENDEXO Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Dr
H965750580BioFlo PICC with ENDEXO Technology (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Dr
H965750570BioFlo PICC with ENDEXO Technology (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated
H965750560BioFlo PICC with ENDEXO Technology (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated
H965750550BioFlo PICC with ENDEXO Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Dual Fenestrated
H965750540BioFlo PICC with ENDEXO Technology (3F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated
H965750530BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Bar
H965750520BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Du
H965750510BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual
H965750500BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Dual Lumen) - Maximal Barrier Dual
H965750490BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Single Lumen) - Maximal Barrier Du
H965750480BioFlo PICC with ENDEXO and PASV Valve Technology (4F x 55cm, Single Lumen) - Maximal Barrier Du
H965750470BioFlo PICC with ENDEXO and PASV Valve Technology (3F x 55cm, Single Lumen) - Maximal Barrier Du
H965750460BioFlo PICC with ENDEXO Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated D
H965750450BioFlo PICC with ENDEXO Technology (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated D
H965750440BioFlo PICC with ENDEXO Technology (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated
H965460290BioFlo Midline with ENDEXO Technology (5F x 20cm, Dual Lumen) - Maximal Barrier Dual Fenestrate
H965460280BioFlo Midline with ENDEXO Technology (5F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra
H965460270BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra
H965460260BioFlo Midline with ENDEXO Technology (3F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra
H965460250BioFlo Midline with ENDEXO Technology (5F x 20cm, Dual Lumen) - Maximal Barrier Dual Fenestrate
H965460240BioFlo Midline with ENDEXO Technology (5F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra
H965460230BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra
H965460220BioFlo Midline with ENDEXO Technology (3F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra
H965PKM1220222S1PICC Convenience Kit
H965PKM1220223S1PICC Convenience Kit
H965PKM1220224S1PICC Convenience Kit
H965PKM220854S1PICC Convenience Kit
H965PKM0116210S1PICC Convenience Kit

Trademark Results [BioFlo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOFLO
BIOFLO
90038587 not registered Live/Pending
Industrial Systems
2020-07-07
BIOFLO
BIOFLO
87649723 5485529 Live/Registered
AngioDynamics, Inc.
2017-10-18
BIOFLO
BIOFLO
86893560 5103418 Live/Registered
AngioDynamics, Inc.
2016-02-01
BIOFLO
BIOFLO
86729361 not registered Dead/Abandoned
AngioDynamics, Inc.
2015-08-19
BIOFLO
BIOFLO
86423436 4751648 Live/Registered
AngioDynamics, Inc.
2014-10-14
BIOFLO
BIOFLO
85564026 4362153 Live/Registered
Bioflo, Inc.
2012-03-08
BIOFLO
BIOFLO
85179751 4350554 Live/Registered
BIOFLO LLC
2010-11-18
BIOFLO
BIOFLO
76497412 2977255 Dead/Cancelled
HYDOR S.R.L.
2003-03-14
BIOFLO
BIOFLO
76469903 2779330 Live/Registered
EPPENDORF, INC.
2002-11-25
BIOFLO
BIOFLO
76209114 2687961 Live/Registered
Allegheny Bradford Corporation
2001-02-12
BIOFLO
BIOFLO
72434756 0975913 Dead/Expired
NEW BRUNSWICK SCIENTIFIC CO., INC.
1972-09-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.