PulseSpray

GUDID H787124007015

PulseSpray Occluding Ball Wire

ANGIODYNAMICS, INC.

Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter
Primary Device IDH787124007015
NIH Device Record Keydcf4277f-0396-4dc2-83da-e855912bea9f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulseSpray
Version Model Number12400701
Company DUNS079105071
Company NameANGIODYNAMICS, 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

Device Dimensions

Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter
Outer Diameter0.035 Inch
Length60 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius
Storage Environment TemperatureBetween 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115051684012997 [Secondary]
HIBCCH787124007010 [Primary]
HIBCCH787124007015 [Package]
Contains: H787124007010
Package: BOX [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, continuous flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-13
Device Publish Date2016-09-19

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