PulseSpray

GUDID H787124011015

PulseSpray Hemostasis Y-Connector

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 IDH787124011015
NIH Device Record Key8718eec2-c762-47d0-8e2d-1b8cf1edc3a2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulseSpray
Version Model Number12401101
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

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
GS115051684013024 [Secondary]
HIBCCH787124011010 [Primary]
HIBCCH787124011015 [Package]
Contains: H787124011010
Package: BOX [5 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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H787125004345PulseSpray Infusion System
H787125004335PulseSpray Infusion System
H787125004325PulseSpray Infusion System
H787125004315PulseSpray Infusion System
H787125004305PulseSpray Infusion System
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H787125004235PulseSpray Infusion System
H787125004225PulseSpray Infusion System
H787125004215PulseSpray Infusion System
H787125004205PulseSpray Infusion System
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H787125004175PulseSpray Infusion System
H787125004165PulseSpray Infusion System

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