Xcela

GUDID H96560M1009221

PICC Convenience Kit

NAVILYST MEDICAL, INC.

Peripherally-inserted central venous catheter
Primary Device IDH96560M1009221
NIH Device Record Key2f9b1aaa-819a-4041-b05f-3061f035b45c
Commercial Distribution StatusIn Commercial Distribution
Brand NameXcela
Version Model Number60M100922
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
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH96560M1009220 [Primary]
HIBCCH96560M1009221 [Package]
Contains: H96560M1009220
Package: BOX [5 Units]
In Commercial Distribution

FDA Product Code

LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-09-17

On-Brand Devices [Xcela]

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
98560873 not registered Live/Pending
Xcela, Inc.
2024-05-21
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.