DEVICE: PleurX (10885403090660)
Device Identifier (DI) Information
PleurX
50-7210
In Commercial Distribution
50-7210
CAREFUSION 2200, INC
50-7210
In Commercial Distribution
50-7210
CAREFUSION 2200, INC
PleurX Vacuum Bottle, With Drainage Line, 1000 mL
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47797 | Pleural/peritoneal drainage catheterization kit |
A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWM | Apparatus, Suction, Patient Care |
PNG | Peritoneal, drainage catheter for refractory ascites, long-term indwelling |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 1000 Milliliter |
Device Record Status
30a04570-50b6-4d53-b4f1-8b1e2f0b63e1
March 10, 2021
4
June 12, 2017
March 10, 2021
4
June 12, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50885403090668 | 10 | 10885403090660 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)323-9088
gmb-MedSpec-CustService@carefusion.com +1(800)323-9088
Customer_Support@BD.com
gmb-MedSpec-CustService@carefusion.com +1(800)323-9088
Customer_Support@BD.com