Xcela

GUDID H965451300

6.6F x 750mm Xcela Plastic Power Injectable Port

NAVILYST MEDICAL, INC.

Infusion/injection port, implantable Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter
Primary Device IDH965451300
NIH Device Record Key86777ee0-a725-4fc4-90c8-57a0a52a1057
Commercial Distribution StatusIn Commercial Distribution
Brand NameXcela
Version Model NumberH965451300
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 Latextrue
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

Device Dimensions

Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge
Length750 Millimeter
Lumen/Inner Diameter1.3 Millimeter
Outer Diameter2.2 Millimeter
Catheter Gauge6.6 French
Needle Gauge17 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640110982310 [Secondary]
HIBCCH965451300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-17

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H965PKM61095323S1PICC Convenience Kit
H96560M2120821PICC Convenience Kit
H965750710Xcela Power Injectable PICC (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nu
H965750700Xcela Power Injectable PICC (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nu
H965750690Xcela Power Injectable PICC (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape
H965750680Xcela Power Injectable PICC (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape
H965440430Xcela Plus Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 8F x 63cm Poly
H965440410Xcela Plus Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Poly
H965440400Xcela Plus Plastic Port with PASV Valve Technology (Filled Suture Holes) and 8F x 63cm Polyureth
H965440390Xcela Plus Plastic Port with PASV Valve Technology (Non-Filled Suture Holes) and 8F x 63cm Polyu
H965440380Xcela Plus Plastic Port with PASV Valve Technology (Filled Suture Holes) and 6F x 63cm Polyureth
H965440370Xcela Plus Plastic Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Polyu
H965440350Xcela Plus Titanium Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter
H965440330Xcela Plus Titanium Port with Non-Filled Suture Holes and 6F x 63cm Polyurethane Catheter
H965440320Xcela Plus Plastic Port with Filled Suture Holes and 8F x 63cm Polyurethane Catheter
H965440310Xcela Plus Plastic Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter
H965440300Xcela Plus Plastic Port with Filled Suture Holes and 6F x 63cm Polyurethane Catheter
H965440290Xcela Plus Plastic Port with Non-Filled Suture Holes and 6F x 63cm Polyurethane Catheter
H96560M1404720PICC Convenience Kit
H96560M1404711PICC Convenience Kit
H96560M1404231PICC Convenience Kit
H96560M1401231PICC Convenience Kit
H96560M1379051PICC Convenience Kit
H96560M1369931PICC Convenience Kit
H96560M1369921PICC Convenience Kit
H96560M1369911PICC Convenience Kit
H96560M1367241PICC Convenience Kit
H96560M1367231PICC Convenience Kit
H96560M1309061PICC Convenience Kit
H96560M1309051PICC Convenience Kit
H96560M1309041PICC Convenience Kit
H96560M1309031PICC Convenience Kit
H96560M1216831PICC Convenience Kit
H96560M1216821PICC Convenience Kit
H96560M1216811PICC Convenience Kit
H96560M1205371PICC Convenience Kit
H96560M1201951PICC Convenience Kit
H96560M1201941PICC Convenience Kit
H96560M1201931PICC Convenience Kit
H96560M1109121PICC Convenience Kit
H96560M1009221PICC Convenience Kit
H96560M1009211PICC Convenience Kit
H96560M0908111PICC Convenience Kit
H96560M0800431PICC Convenience Kit
H96560M0623421PICC Convenience Kit
H96560M0623411PICC Convenience Kit
H96560M0501131PICC Convenience Kit
H96560M0501121PICC Convenience Kit
H96560M0501111PICC Convenience Kit
H96560M0411511PICC Convenience Kit

Trademark Results [Xcela]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XCELA
XCELA
86456391 not registered Live/Pending
Essenlix Corporation
2014-11-17
XCELA
XCELA
77082290 3363005 Live/Registered
NAVILYST MEDICAL, INC.
2007-01-12
XCELA
XCELA
74130696 not registered Dead/Abandoned
Kirschner, Alexander
1991-01-15
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