FDA.reportPublic FDA data

PeritX

Primary DI
50885403500846
Brand
PeritX
Company
CAREFUSION 2200, INC
Model
50-7272
Catalog number
50-7272
Device description
PeritX Valve Kit, For PeritX Peritoneal Catheter Only
Published
2021-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
50885403500846PackageGS15In Commercial Distribution
10885403500848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540350084650885403500846
1088540350084810885403500848

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.

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
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
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450620526Aspira®Merit Medical Systems, Inc.PNG2026-02-27
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