PleurX 50-7000B

GUDID 50885403075979

PleurX Pleural Catheter Kit, For Pleural Placement 15.5 Fr

CAREFUSION 2200, INC

Pleural/peritoneal drainage catheterization kit

• Primary Device ID: 50885403075979
• NIH Device Record Key: 1e9177c3-2a70-445a-adf6-2050e8eb26da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PleurX
• Version Model Number: 50-7000B
• Catalog Number: 50-7000B
• Company DUNS: 832696038
• Company Name: CAREFUSION 2200, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com
• Phone: +1(800)653-6827
• Email: Customer_Support@BD.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403075971 [Primary]
GS1	50885403075979 [Package]; Contains: 10885403075971; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• DWM: APPARATUS, SUCTION, PATIENT CARE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-12
• Device Publish Date: 2017-09-15

On-Brand Devices [PleurX]

• 10885403273773: PleurX Patient Starter Kit, For Patient Home Use - 1000 ml
• 50885403090729: PleurX Vacuum Bottle - Vacuum Bottle with Drainage Line 500ml
• 50885403174870: PleurX Lockable Drainage Line
• 50885403185197: PleurX Lockable Drainage Line Kit
• 50885403090712: PleurX Drainage Kit, 500 ml
• 50885403075979: PleurX Pleural Catheter Kit, For Pleural Placement 15.5 Fr
• 10885403231537: PleurX Peritoneal Catheter and Starter Kit - For Peritoneal Placement Only and For Patient Home
• 50885403231528: PleurX Pleural Catheter and Starter Kit - For Pleural Placement Only and For Patient Home Use
• 50885403193543: PleurX Procedure Pack
• 50885403193024: PleurX Supplemental Insertion Kit
• 50885403185692: PleurX Catheter Access Kit
• 50885403090705: PleurX Drainage Kit 1000 ml (Procedure Pack)
• 50885403090682: PleurX Valve Cap
• 50885403090668: PleurX Vacuum Bottle 1000ml - Vacuum Bottle with Drainage Line
• 50885403075955: PleurX Peritoneal Catheter Kit, For Peritoneal Placement, 15.5 Fr
• 50885403075986: PleurX Pleural Catheter Mini Kit
• 50885403420526: PleurX Valve Kit
• 10885403075964: PLEURX™ PERITONEAL CATHETER MINI KIT