BioFlo

GUDID H96560M1837141

PICC Convenience 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
Primary Device IDH96560M1837141
NIH Device Record Key7b761e73-0d66-4c84-b870-800d705e451f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioFlo
Version Model Number60M183714
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

Device Dimensions

Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
Catheter Gauge5 French
Length55 Centimeter
Device Size Text, specify0
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837140 [Primary]
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution
HIBCCH96560M1837141 [Package]
Contains: H96560M1837140
Package: BOX [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days
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 Date2021-01-13
Device Publish Date2021-01-05

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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
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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
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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
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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

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