PleurX 50-9900

GUDID 10885403231537

PleurX Peritoneal Catheter and Starter Kit - For Peritoneal Placement Only and For Patient Home Use

CAREFUSION 2200, INC

Pleural/peritoneal drainage catheterization kit
Primary Device ID10885403231537
NIH Device Record Keyc2eb04d3-ae16-4518-80e8-bd4881bf2487
Commercial Distribution StatusIn Commercial Distribution
Brand NamePleurX
Version Model Number50-9900
Catalog Number50-9900
Company DUNS832696038
Company NameCAREFUSION 2200, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
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(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com
Phone+1(800)323-9088
EmailCustomer_Support@BD.com

Device Dimensions

Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter
Catheter Gauge15.5 French
Total Volume1000 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110885403231537 [Primary]
GS120885403231534 [Package]
Package: Box [1 Units]
In Commercial Distribution
GS150885403231535 [Package]
Package: Case [1 Units]
In Commercial Distribution

FDA Product Code

PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-13
Device Publish Date2017-09-15

On-Brand Devices [PleurX]

10885403273773PleurX Patient Starter Kit, For Patient Home Use - 1000 ml
50885403090729PleurX Vacuum Bottle - Vacuum Bottle with Drainage Line 500ml
50885403174870PleurX Lockable Drainage Line
50885403185197PleurX Lockable Drainage Line Kit
50885403090712PleurX Drainage Kit, 500 ml
50885403075979PleurX Pleural Catheter Kit, For Pleural Placement 15.5 Fr
10885403231537PleurX Peritoneal Catheter and Starter Kit - For Peritoneal Placement Only and For Patient Home
50885403231528PleurX Pleural Catheter and Starter Kit - For Pleural Placement Only and For Patient Home Use
50885403193543PleurX Procedure Pack
50885403193024PleurX Supplemental Insertion Kit
50885403185692PleurX Catheter Access Kit
50885403090705PleurX Drainage Kit 1000 ml (Procedure Pack)
50885403090682PleurX Valve Cap
50885403090668PleurX Vacuum Bottle 1000ml - Vacuum Bottle with Drainage Line
50885403075955PleurX Peritoneal Catheter Kit, For Peritoneal Placement, 15.5 Fr
50885403075986PleurX Pleural Catheter Mini Kit
50885403420526PleurX Valve Kit

Trademark Results [PleurX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLEURX
PLEURX
75279136 2174010 Live/Registered
CAREFUSION 2200, INC.
1997-04-22

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