FDA.reportPublic FDA data

N/A

Primary DI
50885403502406
Brand
N/A
Company
CAREFUSION 2200, INC
Model
50-7280A
Catalog number
50-7280A
Device description
Catheter Access Kit, For use with the PleurX or PeritX Catheter Systems
Published
2021-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWMAPPARATUS, SUCTION, PATIENT CARE
PNGPeritoneal, drainage catheter for refractory ascites, long-term indwelling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWMApparatus, Suction, Patient CareCardiovascular2
PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term IndwellingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403502406PackageGS15In Commercial Distribution
10885403502408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540350240650885403502406
1088540350240810885403502408

GMDN Terms#

Term, Definition table
TermDefinition
Pleural catheter syringe-infusion setA collection of devices intended to be used in conjunction with a pleural drainage catheter (not included) to manually infuse pharmaceutical agents (e.g., sclerosing agent) [not included] into the pleural cavity, and for catheter flushing/maintenance; it may in addition be intended for manual aspiration of fluids. It includes a catheter/syringe needless valve connector with a syringe and typically additional supportive devices (e.g., clamps, wipes/dressings); it does not include any powered pumps or pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403075995Denver42-200042-20002017-06-12
10885403076008Denver42-205542-20552017-06-12
10885403242342AchieveM1411M14112017-06-12
10885403242359AchieveM1415M14152017-06-12
10885403242366AchieveM1811M18112017-06-12
10885403242373AchieveM1815M18152017-06-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450545010Aspira®Merit Medical Systems, Inc.DWM2026-07-25
00884450545034Aspira®Merit Medical Systems, Inc.DWM2026-07-25
00884450772515Aspira®Merit Medical Systems, Inc.DWM2026-03-27
00884450620588Aspira®Merit Medical Systems, Inc.DWM2026-03-05
10884450620585Aspira®Merit Medical Systems, Inc.DWM2026-03-05
00884450620526Aspira®Merit Medical Systems, Inc.PNG2026-02-27
00884450620540Aspira®Merit Medical Systems, Inc.PNG2026-02-27
00884450620564Aspira®Merit Medical Systems, Inc.DWM2026-02-27
00884450620595Aspira®Merit Medical Systems, Inc.DWM2026-02-27
10884450620523Aspira®Merit Medical Systems, Inc.PNG2026-02-27
10884450620547Aspira®Merit Medical Systems, Inc.PNG2026-02-27
10884450620561Aspira®Merit Medical Systems, Inc.DWM2026-02-27
10884450620592Aspira®Merit Medical Systems, Inc.DWM2026-02-27
00884450620649Aspira®Merit Medical Systems, Inc.DWM2025-10-21
10884450620646Aspira®Merit Medical Systems, Inc.DWM2025-10-21
00884450620601Aspira®Merit Medical Systems, Inc.PNG2025-10-02
10884450620608Aspira®Merit Medical Systems, Inc.PNG2025-10-02
00860009032200Passio Redressing KitBearpac Medical, LLCDWM2025-08-08
00860009032200Passio Redressing KitBearpac Medical, LLCPNG2025-08-08
00860099001315Passio Handheld Control UnitBearpac Medical, LLCDWM2025-07-07
00884450620557Aspira®Merit Medical Systems, Inc.PNG2025-06-03
10884450620554Aspira®Merit Medical Systems, Inc.PNG2025-06-03
00884450620625Aspira®Merit Medical Systems, Inc.DWM2025-05-29
10884450620622Aspira®Merit Medical Systems, Inc.DWM2025-05-29
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