FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594683878
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PGMVTHN17
Catalog number
PGMVTHN17
Device description
KIT, BEDSIDE THORACENTESIS SFT
Published
2022-05-26
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

Product Codes#

Code, Name table
CodeName
PXIThoracentesis tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXIThoracentesis TrayGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594683878PackageGS14In Commercial Distribution
10195594683870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559468387850195594683878
1019559468387010195594683870

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956402898CARDINAL HEALTHCardinal Health 200, LLCPXI2026-04-15
10198956364219CARDINAL HEALTHCardinal Health 200, LLCPXI2026-02-17
50198956364217CARDINAL HEALTHCardinal Health 200, LLCPXI2026-02-17
10198956327948CARDINAL HEALTHCardinal Health 200, LLCPXI2026-02-12
10198956161825CARDINAL HEALTHCardinal Health 200, LLCPXI2025-11-07
10198956127333CARDINAL HEALTHCardinal Health 200, LLCPXI2025-07-22
50198956127331CARDINAL HEALTHCardinal Health 200, LLCPXI2025-07-22
10198956074835CARDINAL HEALTHCardinal Health 200, LLCPXI2025-06-05
50198956074833CARDINAL HEALTHCardinal Health 200, LLCPXI2025-06-05
10198956051324CARDINAL HEALTHCardinal Health 200, LLCPXI2025-04-23
50198956051322CARDINAL HEALTHCardinal Health 200, LLCPXI2025-04-23
10197106646472CARDINAL HEALTHCardinal Health 200, LLCPXI2024-05-30
50197106646470CARDINAL HEALTHCardinal Health 200, LLCPXI2024-05-30
16931918132648InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2024-04-26
26931918132645InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2024-04-26
16931918164335InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2024-02-02
26931918164332InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2024-02-02
16931918171470InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-27
16931918190280InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-27
26931918171477InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-27
26931918190287InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-27
16931918121215InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-20
26931918121212InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-20
10197106328781CARDINAL HEALTHCardinal Health 200, LLCPXI2023-08-21
50197106328789CARDINAL HEALTHCardinal Health 200, LLCPXI2023-08-21
10197106150702CARDINAL HEALTHCardinal Health 200, LLCPXI2023-05-01
50197106150700CARDINAL HEALTHCardinal Health 200, LLCPXI2023-05-01
00884450277843Thoracentesis and Paracentesis SetMerit Medical Systems, Inc.PXI2022-12-02
10884450277840Thoracentesis and Paracentesis SetMerit Medical Systems, Inc.PXI2022-12-02
00884450277751Thoracentesis and Paracentesis SetMerit Medical Systems, Inc.PXI2022-10-18