Uni-Fuse+

GUDID 15051684023924

Uni-Fuse+ Infusion System 5F, 90cm, 2cm

ANGIODYNAMICS, INC.

Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter
Primary Device ID15051684023924
NIH Device Record Key7ad8cae1-d67d-4978-a29f-11a69ee1bed7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUni-Fuse+
Version Model Number12401861
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

Device Dimensions

Length90 Centimeter
Outer Diameter1.71 Millimeter
Catheter Gauge5 French
Length90 Centimeter
Outer Diameter1.71 Millimeter
Catheter Gauge5 French
Length90 Centimeter
Outer Diameter1.71 Millimeter
Catheter Gauge5 French
Length90 Centimeter
Outer Diameter1.71 Millimeter
Catheter Gauge5 French
Length90 Centimeter
Outer Diameter1.71 Millimeter
Catheter Gauge5 French
Length90 Centimeter
Outer Diameter1.71 Millimeter
Catheter Gauge5 French
Length90 Centimeter
Outer Diameter1.71 Millimeter
Catheter Gauge5 French
Length90 Centimeter
Outer Diameter1.71 Millimeter
Catheter Gauge5 French

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

Device Identifiers

Device Issuing AgencyDevice ID
GS115051684023924 [Secondary]
GS115051684023924 [Secondary]
GS115051684023924 [Secondary]
GS115051684023924 [Secondary]
GS115051684023924 [Secondary]
GS115051684023924 [Secondary]
GS115051684023924 [Secondary]
GS115051684023924 [Secondary]
HIBCCH787124018610 [Primary]
HIBCCH787124018610 [Primary]
HIBCCH787124018610 [Primary]
HIBCCH787124018610 [Primary]
HIBCCH787124018610 [Primary]
HIBCCH787124018610 [Primary]
HIBCCH787124018610 [Primary]
HIBCCH787124018610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, continuous flush
KRACatheter, continuous flush
KRACatheter, continuous flush
KRACatheter, continuous flush
KRACatheter, continuous flush
KRACatheter, continuous flush
KRACatheter, continuous flush
KRACatheter, continuous flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Uni-Fuse+]

15051684023955Uni-Fuse+ Infusion System 5F, 135cm, 15cm
15051684023948Uni-Fuse+ Infusion System 5F, 135cm, 2cm
15051684023931Uni-Fuse+ Infusion System 5F, 90cm, 15cm
15051684023924Uni-Fuse+ Infusion System 5F, 90cm, 2cm
15051684023917Uni-Fuse+ Infusion System 4.3F, 135cm, 15cm
15051684023900Uni-Fuse+ Infusion System 4.3F, 135cm, 2cm
15051684023894Uni-Fuse+ Infusion System 4.3F, 90cm, 15cm
15051684023887Uni-Fuse+ Infusion System 4.3F, 90cm, 2cm
15051684023870Uni-Fuse+ Infusion System 4.3F, 135cm, 10cm
15051684023863Uni-Fuse+ Infusion System 4.3F, 135cm, 5cm
15051684023856Uni-Fuse+ Infusion System 4.3F, 90cm, 10cm
15051684023849Uni-Fuse+ Infusion System 4.3F, 90cm, 5cm
15051684023832Uni-Fuse+ Infusion System 5F, 135cm, 10cm
15051684023825Uni-Fuse+ Infusion System 5F, 135cm, 5cm
15051684023818Uni-Fuse+ Infusion System 5F, 90cm, 10cm
15051684023801Uni-Fuse+ Infusion System 5F, 90cm, 5cm

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