FDA.reportPublic FDA data

PleurX

Primary DI
10885403231537
Brand
PleurX
Company
CAREFUSION 2200, INC
Model
50-9900
Catalog number
50-9900
Device description
PleurX Peritoneal Catheter and Starter Kit - For Peritoneal Placement Only and For Patient Home Use
Published
2017-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term IndwellingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403231534PackageGS11In Commercial Distribution
50885403231535PackageGS11In Commercial Distribution
10885403231537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540323153420885403231534
5088540323153550885403231535
1088540323153710885403231537

GMDN Terms#

Term, Definition table
TermDefinition
Pleural/peritoneal drainage catheterization kitA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15.5French
Total Volume1000Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)323-9088Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450620540Aspira®Merit Medical Systems, Inc.PNG2026-02-27
10884450620523Aspira®Merit Medical Systems, Inc.PNG2026-02-27
10884450620547Aspira®Merit Medical Systems, Inc.PNG2026-02-27
00884450620601Aspira®Merit Medical Systems, Inc.PNG2025-10-02
10884450620608Aspira®Merit Medical Systems, Inc.PNG2025-10-02
00860009032200Passio Redressing KitBearpac Medical, LLCPNG2025-08-08
00884450620557Aspira®Merit Medical Systems, Inc.PNG2025-06-03
10884450620554Aspira®Merit Medical Systems, Inc.PNG2025-06-03
00884450544969Aspira®Merit Medical Systems, Inc.PNG2025-04-21
10884450544966Aspira®Merit Medical Systems, Inc.PNG2025-04-21
00884450751305Aspira®Merit Medical Systems, Inc.PNG2025-04-21
00801741230608PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00801741230615PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00801741230639PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230605PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230612PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230636PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00884450544952Aspira®Merit Medical Systems, Inc.PNG2024-03-06
10884450544959Aspira®Merit Medical Systems, Inc.PNG2024-03-06
00086000903220Passio Redressing KitBearpac Medical, LLCPNG2024-02-29
00860099001322Passio Pump Drainage SystemBearpac Medical, LLCPNG2023-08-11
00884450534311Aspira®Merit Medical Systems, Inc.PNG2022-12-07
10884450534318Aspira®Merit Medical Systems, Inc.PNG2022-12-07
00884450534304Aspira®Merit Medical Systems, Inc.PNG2022-03-16
10884450534301Aspira®Merit Medical Systems, Inc.PNG2022-03-16
10885403500831PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403500848PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403502040PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403502378N/ACAREFUSION 2200, INCPNG2021-03-09